OsteoMed 206-2408Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845694000758), received between Jul 12, 2023 and Sep 15, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Break

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50780696 ↗
• InjuryJul 12, 2023Off-Label Use; Off-Label Use

  IT WAS REPORTED DURING THE SURGERY, THE SURGEON NOTED THAT THE OSTEOMED SCREW WAS TOO LARGE TO FIT INTO THE PILOT DRILL HOLE. THE SURGEON NOTED THAT THE SCREW WAS LARGER AND REPORTED THIS TO THE SALES REPRESENTATIVE OF ANOTHER MANUFACTURER. THIS SALES REPRESENTATIVE NOTED THE OSTEOMED SCREW WAS LARGER WHEN COMPARING IT TO OTHER OSTEOMED SCREWS THAT WERE SENT IN THE KIT. THIS PROCEDURE WAS COMPLETED WITH ADDITIONAL SCREWS THAT HAD BEEN PROVIDED OF THE SAME TYPE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED, AND THE SURGERY WAS NOT PROLONGED. DURING THE COURSE OF FOLLOW UP, IT WAS DETERMINED THAT THESE OSTEOMED SCREWS WERE PROVIDED IN THEIR PACKAGING TO ANOTHER MANUFACTURER WHO THEN IS LOADING THESE SCREWS INTO A KIT CONTAINING THAT MANUFACTURER'S IMPLANT. THESE SCREWS ARE BEING USED WITH THAT MANUFACTURER'S TMJ PROTHESIS/IMPLANT. THIS IS OFF-LABEL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309783 ↗