LYOPLANT ONLAY 1067040Recalls & reported problems
Aesculap AG · LYOPLANT ONLAY 7.5X7.5CM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963958701), received between Apr 21, 2021 and Apr 21, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Degraded” (2 reports).
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
- Degraded2
Patient problems
- Failure of Implant2
- Cerebrospinal Fluid Leakage1
- Meningitis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2021Degraded; Degraded
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH 1067040 - LYOPLANT ONLAY 7.5X7.5CM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SURGEON PLACED LYOPLANT ONLAY ON A PATIENT, AND THE PATIENT DEVELOPED A PSEUDOMENINGOCELE AND CHEMICAL MENINGITIS. HE TOOK THE PATIENT BACK TO THE OPERATION ROOM, 3 1/2 MONTHS AFTER INITIAL IMPLANTATION, THINKING MAYBE A SUTURE HAD COME LOSE. HOWEVER, THE SUTURES WERE ALL IN PLACE AND THERE WAS A DEHISCENCE OF THE LYPLANT ONLAY AND CEREBROSPINAL FLUID (CSF) WAS LEAKING OUT". A REVISION SURGERY WAS NECESSARY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: Failure of Implant; Meningitis
MAUDE report 11700564 ↗InjuryApr 21, 2021Degraded; Degraded
NO CHANGES REQUIRED.
Patient problems: Cerebrospinal Fluid Leakage; Failure of Implant
MAUDE report 11700475 ↗
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- 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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