Durepair® 62100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169063853), received between Apr 15, 2022 and Apr 25, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING A DEVICE FOR CRANIAL REPAIR. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED IN MARCH OF LAST YEAR. THEY SAID THAT THERE WAS A LEAK THAT HAD SINCE BEEN CONTROLLED AND HAD BEEN IN CONTACT WITH THEIR DOCTOR.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 19182140 ↗
• InjuryFeb 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A DEVICE USED FOR CRANIAL REPAIR. IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE, AND THE PATIENT SUSTAINED PERSONAL INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18738621 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A UNKNOWN DURAREPAIR. IT WAS REPORTED THAT A PATIENT HAD AN ADVERSE REACTION. RIGHT POSTERIOR FOSSA CRANIOTOMY PERFORMED ON (B)(6) 2023 - MEDTRONIC DUREPAIR DEVICE, 62110, LOT 2207017. ON (B)(6) 2023 PATIENT DEVELOPED HEADACHES, INCREASED FATIGUE, FEVER AND WOUND DRAINAGE - COPIOUS PURULENT YELLOW DRAINAGE. URGENT MRI CONDUCTED ON (B)(6) 2023 AND DEMONSTRATED DEEP WOUND INFECTION. PATIENT BROUGHT EMERGENTLY TO THE OPERATING ROOM ON (B)(6) 2023 FOR IRRIGATION, DEBRIDEMENT, CRANIECTOMY AND WOUND CLOSURE. LUMBAR CSF DRAIN ALSO PLACED. THE PRIOR DURAPLASTY REPAIR APPEARED MACERATED AND 3 FOCAL AREAS OF CSF EGRESS UNDER PRESSURE WERE IDENTIFIED. REPEAT SURGERY CONDUCTED ON (B)(6) 2023 AFTER THE LUMBAR DRAIN HAD BEEN REMOVED AS PATIENT DEVELOPED CSF LEAK AGAIN. PERFORMED EXTERNAL VENTRICULOSTOMY AND DRAIN PLACEMENT TO PROVIDE CSF DIVERSION. CSF SENT FOR CULTURE, WHICH WAS POSITIVE FOR MRSA. ON (B)(6) 2023 THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM TO PLACE A VENTRICULOPERITONEAL SHUNT FOR POSTINFECTIOUS HYDROCEPHALUS. ON (B)(6) 2023 IT WAS IDENTIFIED THAT THE PATIENT MET CRITERIA FOR AN ORGAN SPACE SSI.

  Patient problems: Local Reaction

  MAUDE report 17288801 ↗
• OtherJun 22, 2023Nonstandard Device

  DUREPAIR DURA REGENERATION MATRIX - ALL LOT NUMBERS - URGENT MEDICAL DEVICE RECALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192266 ↗
• InjuryApr 15, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A DUREPAIR. IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WAS PERFORMING A CHIARI MALFORMATION PROCEDURE ON (B)(6) 2022. THE HCP USED A 2X2 INCH DUREPAIR. THE PATIENT DEVELOPED A PSEUDOMENINGOCELE. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2022 AND THE HCP STATED THAT THE DUREPAIR HAD DISINTEGRATED. DURING THE PROCEDURE ON APRIL 8TH THE HCP USED DUREPAIR AND IT KEPT TEARING AND THE SUTURE WAS PULLING THROUGH.

  Patient problems: Hydrocephalus

  MAUDE report 14120427 ↗
• InjuryApr 15, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A DUREPAIR. IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WAS PERFORMING A CHIARI MALFORMATION PROCEDURE ON (B)(6) 2022. THE HCP USED A 2X2 INCH DUREPAIR. THE PATIENT DEVELOPED A PSEUDOMENINGOCELE. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2022 AND THE HCP STATED THAT THE DUREPAIR HAD DISINTEGRATED. DURING THE PROCEDURE ON (B)(6) 2022 THE HCP USED DUREPAIR AND IT KEPT TEARING AND THE SUTURE WAS PULLING THROUGH.

  Patient problems: Hydrocephalus

  MAUDE report 14120422 ↗