Biosteon® Screw 234-010-162Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15060155710256), received between Oct 29, 2020 and Apr 4, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2022Break

  IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE AND POTENTIALLY REMAINS IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14002843 ↗
• InjuryJun 9, 2021Fitting Problem; Break; Entrapment of Device; Fitting Problem

  IT WAS REPORTED THAT THE SCREW BROKE AND PIECES WERE POTENTIALLY REMAINING IN THE PATIENT.

  Patient problems: Failure of Implant; Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971467 ↗
• InjuryOct 30, 2020Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE SCREW BROKE AND PART OF IT REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10760005 ↗
• InjuryOct 29, 2020Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE SCREW BROKE AND PART OF IT REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10759931 ↗