NEURO-PATCH 1064037Recalls & reported problems
Aesculap AG · NEURO-PATCH 4X10CM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653700790), received between Dec 3, 2021 and Dec 3, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED TO AESCULAP AG THAT A NEURO-PATCH 4X10CM (PART # 1064037) WAS USED DURING A CRANIOTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT A CRANIOTOMY PROCEDURE FOR A TUMOR AND HAD A NEUROPATCH PLACED. REPORTEDLY, THE DEVICE LEAKED IN CENTRAL AREA ONE WEEK AFTER SURGERY. REPORTEDLY, WHEN THE CONTROL WAS PERFORMED, FLUID WAS OBSERVED IN THE BRAIN AND A FOLLOWUP OPERATION WAS SCHEDULED. DURING THIS OPERATION, THE LEAK WAS VERIFIED IN THE CENTRAL PART OF THE PATCH. A SECOND NEUROPATCH WAS PLACED WHICH PRESENTED WITH A LIVE LEAK DURING THE SURGERY. THE PATIENT WAS OPERATED A THIRD TIME WITH PLACEMENT OF HIS OWN MUSCLE PART. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12925694 ↗
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- Durepair® 62110Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall3 reports
- DuraMatrix Onlay CDSLM45Collagen Matrix, Inc. · Dura Substitute1 recall3 reports
- Durepair® 62111Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall1 report
- Durepair® 62106Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall1 report
- Durepair® 62158Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall0 reports
- DURAFORM 80-1477USCerenovus, Inc. · DURA SUBSTITUTE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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