OSSEOTITE® OSM313Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® IMPLANT 3.25 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 00844868012962), received between Jun 26, 2021 and Jun 6, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (3 reports).
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
- Fracture3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2025Fracture; Fracture
DOCTOR REPORTED IMPLANT FRACTURE AT TOOTH SITE 41. OSTEOTOMY WAS PERFORMED. SITE PRESENTED ABSCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22157043 ↗InjuryAug 6, 2021Fracture; Fracture
THE DOCTOR REPORTS THAT TWO (2) IMPLANTS WERE FRACTURED TWO (2) AND A HALF YEARS AFTER THEIR PLACEMENT IN DENTAL POSITIONS #12 AND #22 RESPECTIVELY. THE DOCTOR INFORMS THAT THE PATIENT DID NOT SUFFER ANY IMPACT ON HIS HEALTH AND THAT THE PATIENT MUST RETURN TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12287707 ↗InjuryAug 6, 2021Fracture; Fracture
THE DOCTOR REPORTS THAT TWO (2) IMPLANTS WERE FRACTURED TWO (2) AND A HALF YEARS AFTER THEIR PLACEMENT IN DENTAL POSITIONS #12 AND #22 RESPECTIVELY. THE DOCTOR INFORMS THAT THE PATIENT DID NOT SUFFER ANY IMPACT ON HIS HEALTH AND THAT THE PATIENT MUST RETURN TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12287681 ↗InjuryJun 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT AT TOOTH SITE# 26 WAS REMOVED DUE TO LACK OF PRIMARY STABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12072446 ↗
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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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