CERTAIN® PREVAIL® IIOS4310Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® PREVAIL® IMPLANT 4/3 X 10MM · 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 00844868005797), received between Oct 23, 2020 and Oct 23, 2020 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT HAD BONE LOSS REQUIRING REMOVAL. IMPLANT WAS REMOVED AND BACKED OUT WITH THE PLACEMENT DRIVER AND SITE WAS CURETTED AND GRAFTED. PENVK RX WAS PRESCRIBED AS WELL. PT WILL RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #4.
Patient problems: No Code Available
MAUDE report 10728406 ↗
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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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