LOCKING SCREW 1312-20-418Recalls & reported problems
Biomet Orthopedics, LLC · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00887868013669), 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 17372397 ↗
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- SMART TOE ST0-19PStryker GmbH · PIN, FIXATION, SMOOTH1 recall2 reports
- HammerTube™ System P40-002-0275-SParagon 28, Inc. · PIN, FIXATION, SMOOTH1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
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- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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