LYOPLANT 1066064Recalls & reported problems
Aesculap AG · LYOPLANT 4X5CM · 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 04038653700967), received between Oct 15, 2020 and Oct 15, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
- Patient Device Interaction Problem1
Patient problems
- Cerebrospinal Fluid Leakage1
- 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.
InjuryOct 15, 2020Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem
ADDITIONAL INFORMATION WAS RECEIVED: THE CURRENT PATIENT STATUS IS STABLE POSTOPERATIVELY, AND IT WAS CONFIRMED THAT THE ONLY INTERVENTION REQUIRED WAS THE READMISSION FOR CSF LEAK; AND SURGERY OCCURRED TO REPAIR AND PATCH (WITH PATIENTS OWN TISSUE). SUTURING OF THE ORIGINAL LYOPLANT DURAL GRAFT WAS PERFORMED WITH 5-0 PROLENE SUTURE. THE OPERATIVE REPORT AND MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME AND THERE WERE NO PICTURES NOR X-RAYS TAKEN.
Patient problems: Cerebrospinal Fluid Leakage; No Clinical Signs, Symptoms or Conditions
MAUDE report 10682974 ↗
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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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