OSSEOTITE® NT513Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® TAPERED IMPLANT 5 X 13MM · Class 2 · Implant
All models of OSSEOTITE (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844868012085), received between Dec 12, 2019 and Feb 3, 2026 — classified as 4 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- No Information2
- Pain2
- Abscess1
- Nerve Damage1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
THE IMPLANT WAS REMOVED DUE TO A NERVE INJURY AT TOOTH SITE #14. THE PATIENT EXPERIENCED ACUTE PAIN. A NEW IMPLANT WILL BE PLACED ONCE THE AREA IS REGENERATED.
Patient problems: Nerve Damage; Pain
MAUDE report 24244401 ↗InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTED THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER 47 FAILED BECAUSE THE PATIENT COMPLAINED OF PAIN AND SUPPURATION. THE DOCTOR REPORTED INFECTION AND ABSCESS. THE DOCTOR CONFIRMED THAT THE PROCEDURE WAS NOT COMPLETED USING ANOTHER IMPLANT BECAUSE THE PATIENT DOES NOT WANT TO REPLACE IT.
Patient problems: Abscess; Pain; Unspecified Infection
MAUDE report 17132747 ↗InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT HAD LACK OF PRIMARY STABILITY WHEN PLACING AND WAS REMOVED. NO OTHER IMPLANT WAS PLACED DURING THE SURGERY.
Patient problems: No Information
MAUDE report 9457204 ↗InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 19 LACKED PRIMARY STABILITY WHEN PLACING AND WAS REMOVED. NO OTHER IMPLANT WAS PLACE DURING THE SURGERY.
Patient problems: No Information
MAUDE report 9457099 ↗
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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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