Durepair® 62110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169063884), received between Aug 15, 2023 and Mar 25, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A DEVICE USED FOR CRANIAL REPAIR. IT WAS REPORTED THAT A PATIENT DID WELL FOR SOME TIME AFTER A TETHERED CORD RELEASE WITH EXPANSILE PATCH DURAPLASTY AND INTRAOPERATIVE ULTRASOUND BUT DEVELOPED A DELAYED PSEUDOMENINGOCELE FOR WHICH THE SITE PERFORMED A VENTRICULOPERITONEAL (VP) SHUNT EXPLORATION WHICH WAS FOUND TO BE FUNCTIONAL, AS WELL AS A LUMBAR WOUND EXPLORATION, AND CEREBROSPINAL FLUID (CSF) LEAK REPAIR WITH REVISION DURAPLASTY DUE TO A CONCERN FOR AN ISSUE WITH THE DURAL SUBSTITUTE PATCH WHICH WAS CONFIRMED WITH A COMPLEX PLASTIC SURGERY CLOSURE. PATIENT DID EXTREMELY WELL FROM THIS OPERATION, AND HAD BEEN AT HOME. VISITING THE SITE TODAY WAS THE PATIENT'S FIRST TIME LEAVING THEIR HOUSE SINCE SURGERY. OVERALL THEY WERE DOING QUITE WELL. PREOPERATIVELY, THEY WERE EXPERIENCING SIGNIFICANT HEADACHES WHICH HAD SINCE COMPLETELY RESOLVED. PATIENT WAS ALSO EXPERIENCING SIGNIFICANT BACK PAIN WITH TENDERNESS TO TOUCH OF THEIR BACK DUE TO A LARGE PSEUDOMENINGOCELE THAT WAS PRESENT BUT CONTAINED WITHIN THE SKIN. THIS WAS ALSO IMPROVED SIGNIFICANTLY SINCE SURGERY, AND THEY WERE ESSENTIALLY PAIN-FREE. THE PATIENT DID NOT HAVE ANY RADICULAR PAIN, AN

  Patient problems: Cerebrospinal Fluid Leakage; Discomfort; Headache; Pain

  MAUDE report 18969199 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A DEVICE USED FOR CRANIAL REPAIR. IT WAS REPORTED THAT A PATIENT WITH HISTORY OF MYELOMENINGOCELE AND TETHERED SPINAL CORD WHO UNDERWENT A TETHERED CORD RELEASE WITH PATCH DURAPLASTY USING INTRAOPERATIVE ULTRASOUND AND OPERATING MICROSCOPE ALMOST A YEAR AGO, WHICH WAS COMPLICATED BY A SYMPTOMATIC PSEUDOMENINGOCELE REQUIRING RE-EXPLORATION AND CEREBROSPINAL FLUID (CSF) LEAK REPAIR, AS WELL AS RECURRENT CSF LEAK REQUIRING RE-EXPLORATION, VENTRICULOPERITONEAL SHUNT PLACEMENT AND COMPLEX PLASTIC SURGERY CLOSURE, WHOSE COURSE WAS ALSO COMPLICATED BY DEHISCENCE OF THE SHUNT INCISION WHICH REQUIRED SHUNT REMOVAL. MOST RECENTLY, THE PATIENT HAD ANOTHER DELAYED RE-ACCUMULATION OF A PSEUDOMENINGOCELE WHICH CAUSED BACK AND LEG PAIN, FOR WHICH THE SITE ADMITTED THEM TO THE HOSPITAL AND PERFORMED A LUMBAR WOUND TAP, EXTERNAL VENTRICULAR DRAIN (EVD) PLACEMENT, CONFIRMED CULTURES NEGATIVE, AND PLACED A LEFT VENTRICULOPERITONEAL SHUNT. AFTER THESE PROCEDURES, THE PATIENT WAS AMBULATORY WITHOUT BACK OR LEG PAIN. THEY WERE EVENTUALLY DISCHARGED IN FAIRLY GOOD CONDITION AND HAD BEEN AT HOME. SINCE THEN THEIR BACK PAIN HAS REOCCURRED, AND THEY WERE ALSO EXPERIE

  Patient problems: Cerebrospinal Fluid Leakage; Cramp(s) /Muscle Spasm(s); Impaired Healing; Pain

  MAUDE report 18968451 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT DEVICE REMOVAL RESOLVED THE EVENT.

  Patient problems: Headache; Pain; Unspecified Infection

  MAUDE report 17550992 ↗