NANOTITE™CERTAIN®PREVAIL® NIIOS4510Recalls & reported problems
ZimVie US Corp LLC · NANOTITE TM CERTAIN® PREVAIL® IMPLANT 4/5/4 X 10MM · Class 2 · Implant
All models of NANOTITECERTAINPREVAIL (12)
Data updated Oct 18, 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 00844868010777), received between Jun 15, 2020 and Jun 15, 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 18, 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.
InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ABUTMENT SCREW FRACTURED AT TOOTH LOCATION 19. CROWN ON IMPLANT REMADE LAST YEAR. NOW ABUTMENT SCREW FRACTURED AND ADVANCED BONE LOSS AROUND THE IMPLANT NON SALVAGEABLE. THE FRACTURED SCREW AND BONE LOSS WAS DISCOVERED AT THE SAME TIME.
Patient problems: No Code Available
MAUDE report 10155515 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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