OsteoMed 317-3034Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694027489), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 malfunction.

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. 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.

• MalfunctionMar 6, 2019Break

  ON (B)(6) 2019, OSTEOMED WAS NOTIFIED OF AN INCIDENT CONCERNING ONE OF OUR CANNULATED HEADLESS SCREWS. PER THE DISTRIBUTOR, THE PHYSICIAN PERFORMED AN MTP FUSION ON A PATIENT IN 2017. HE USED A 3.0 CANNULATED SCREW AND 4.0 CANNULATED SCREW TO GAIN JOIN COMPRESSION. ANOTHER PHYSICIAN FROM THE OFFICE CONTACTED THE DISTRIBUTOR TO REQUEST HIS DRIVERS TO REMOVE A BROKEN 3.0MM CANNULATED SCREW. THE DISTRIBUTOR WAS NOT ABLE TO ATTEND THE PROCEDURE AND FOLLOWED UP WITH THE PHYSICIAN TO FIND OUT IF HE WAS ABLE TO GET THE ENTIRE SCREW OUT. THE PHYSICIAN STATED THAT HE WAS ABLE TO GET ½ OF THE SCREW OUT, BUT THE PROXIMAL ½ OF THE SCREW WAS LEFT IN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8396962 ↗