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Durepair® 62111Recalls & reported problems

Medtronic Ps Medical, Inc. · DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169063891), received between Jul 10, 2023 and Jul 10, 2023 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jun 13, 2023Open, Classified

    Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs and symptoms of an acute inflammatory process, comparable to infection.

    Z-2207-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Local Reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT HAD AN ADVERSE REACTION. RIGHT L2, L3, L4 LAMINOTOMIES PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, PATIENT EXPERIENCED A SURGICAL WOUND DEHISCENCE AND INFECTION. OUTPATIENT CULTURES REVEALED MSSA. ON (B)(6)2022 PATIENT RETURNED TO THE OR FOR WOUND DEBRIDEMENT, DURAPLASTY AND CLOSURE OF WOUND DEHISCENCE. PATIENT STARTED ON IV CEFTRIAXONE FOR 6 WEEKS FROM (B)(6) 2022. A DUREPAIR WAS IMPLANTED.

    Patient problems: Local Reaction

    MAUDE report 17288909 ↗

Other DURA SUBSTITUTE devices

All DURA SUBSTITUTE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.