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Durepair® 62106Recalls & reported problems

Medtronic Ps Medical, Inc. · DURA 62106 SUBSTITUTE DUREPAIR 1X3IN 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 00643169063877), received between Sep 27, 2019 and Sep 27, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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

  • Fluid/Blood Leak1
  • Material Disintegration1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjurySep 27, 2019Material Disintegration; Fluid/Blood Leak; Material Disintegration; Fluid/Blood Leak

    IT WAS REPORTED THAT IN LATE 2018, THE PATIENT WAS DIAGNOSED WITH WEAKNESS IN HER LEFT ARM; SHE WAS UNABLE TO LIFT HER ARM ABOVE 40 DEGREES PROXIMALLY. A CERVICAL MRI SHOWED A LARGE CYST AT THE C4-05 LEVEL. INITIALLY, DOCTORS RECOMMENDED AND THE PATIENT UNDERWENT CONSERVATIVE TREATMENT TO STRENGTHEN HER LEFT ARM, BUT THAT WASN'T SUCCESSFUL. THE PATIENT UNDERWENT A LAMINOPLASTY WITH RESECTION OF THE CYST AND DURAPLASTY ON (B)(6) 2019. DURING THIS SURGERY, THE PATIENT'S PHYSICIAN UTILIZED THE REPORTED DEVICE. HOWEVER, THIS PRODUCT DID NOT PERFORM AS EXPECTED AND AS IT SHOULD HAVE. AS A DIRECT AND PROXIMATE RESULT OF, THE PATIENT SUFFERED A CEREBROSPINAL FLUID LEAK. THE PATIENT SOON SUFFERED FROM HEADACHES, NAUSEA, VOMITING, AND GAIT DEFICIT. SHE WAS ADMITTED TO THE EMERGENCY ROOM AT THE HOSPITAL, WHERE HER DOCTORS QUICKLY FOUND THAT THE DURAPLASTY HAD FAILED WHERE THE DURAL PATCH HAD ALMOST DISINTEGRATED. THE PATIENT UNDERWENT A REPAIR OF CERVICAL DURAPLASTY ON (B)(6) 2019. SINCE THAT TIME, SHE IS UNABLE TO WALK WITHOUT THE ASSISTANCE OF THE WALKER, AND SHE HAS SUFFERED FROM CONTINUAL BACK, SHOULDER, AND NECK PAIN. SHE HAS ALSO COMPLAINED OF ARM AND LEG NUMBNESS, TINGLING, AND LEG SP

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 9128568 ↗

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.