OsteoMed 316-0017Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694035613), received between Dec 13, 2023 and Dec 13, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING THE TRIPLE ANKLE ARTHODESIS SURGERY, THE SPECIALIST DECIDES TO PLACE A CANULATED SCREW WITH A 6.5MM HEAD FROM THE CANULATED SET. AT THE TIME OF PLACING THIS SCREW, THE SPECIALIST IMPLANTS A 2.8 GUIDE AND WHEN HE IS GOING TO ENHANCE THE MEASUREMENT WITH THE DEPTH GAUGE (PART NUMBER 316-0017), IT WAS NOTED THE GUIDE DID NOT GO THROUGH THE DEPTH GAUGE. THE SPECIALIST TRIED TO CHANGE GUIDES BUT NONE OF THE GUIDES IN THE SET WENT THROUGH THE DEPTH GAUGE, THE SPECIALIST MEASURED WITH THE HELP OF ANOTHER GUIDE TO COMPLETE THE SURGERY. THIS PROLONGED THE SURGERY BY 35 MINUTES. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318291 ↗