Medtronic Puerto Rico Operations Co.

⚠️ High Risk

FEI: 2647346 • Humacao, PR • UNITED STATES

FEI

FEI Number

2647346

📍

Location

Humacao, PR

🇺🇸

Country

UNITED STATES

🏢

Address

Rd 909 Km 0.4, , Humacao, PR, United States

High Risk

FDA Import Risk Assessment

57.5

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

2/11/2016

Latest Refusal

11/10/2014

Earliest Refusal

Score Breakdown

Violation Severity

63.4×40%

Refusal Volume

73.8×30%

Recency

0.0×20%

Frequency

100.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

11886×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

23769×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

Date	Product	Violations	Division
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
2/11/2016	87MNIORTHOSIS, SPINAL PEDICLE FIXATION	118NOT LISTED	Division of Southeast Imports (DSEI)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)
11/10/2014	87NKBORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE	118NOT LISTED 237NO PMA	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Medtronic Puerto Rico Operations Co.'s FDA import refusal history?

Medtronic Puerto Rico Operations Co. (FEI: 2647346) has 97 FDA import refusal record(s) in our database, spanning from 11/10/2014 to 2/11/2016.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Medtronic Puerto Rico Operations Co.'s FEI number is 2647346.

What types of violations has Medtronic Puerto Rico Operations Co. received?

Medtronic Puerto Rico Operations Co. has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Medtronic Puerto Rico Operations Co. come from?

All FDA import refusal data for Medtronic Puerto Rico Operations Co. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.