Vitelene® NV301ERecalls & reported problems
Aesculap AG · VITELENE INSERT E 32MM POST.WALL · Class 2 · Implant
Data updated Oct 16, 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 04046963973872), received between Feb 26, 2021 and Feb 26, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Insert” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Difficult to Insert1
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.
InjuryFeb 26, 2021Difficult to Insert; Difficult to Insert
IT WAS REPORTED TO AESCULAP AG THAT A PLASMAFIT POLY CUP (PART # NV046T) WAS IMPLANTED DURING AN ORTHOPEDIC PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VITELENE INLAY (PART # NV301E) WAS NOT ABLE TO BE INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER VITELENE INLAY. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00158 (400503264 + NV301E), 9610612-2021-00104 (400501782 + NV046T).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11388498 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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