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LOCKING SCREW 1312-20-420Recalls & reported problems

Biomet Orthopedics, LLC · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868013676), received between Jul 21, 2023 and Jul 21, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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

Device problems

  • Migration or Expulsion of Device1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryJul 21, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED THAT DURING A ROUTINE RADIOGRAPH, IT WAS FOUND THAT THE IMPLANTED PLATE WAS FRACTURED. THE PATIENT STATES THERE WAS NO FALL, INJURY, OR VIOLENCE WHICH WOULD HAVE CAUSED THIS FRACTURE. THE PATIENT WAS REVISED APPROXIMATELY 2 MONTHS POST IMPLANTATION. RADIOGRAPHIC REVIEW FURTHER DISCOVERED THAT THERE WAS PARTIAL WITHDRAWAL OF THE TRAPEZIUM SCREW IN ADDITION TO THE IMPLANT FRACTURE AND MALUNION. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Patient problems: Failure of Implant

    MAUDE report 17372453 ↗

Other PIN, FIXATION, THREADED devices

All PIN, FIXATION, THREADED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.