Biosteon® Screw 234-010-163Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15060155710263), received between Aug 13, 2021 and Apr 4, 2022 — classified as 4 injuries.

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.

• InjuryApr 4, 2022Break; Break

  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 14004409 ↗
• InjuryApr 4, 2022Break; Break

  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 14004111 ↗
• InjuryApr 4, 2022Break; Break

  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 14003984 ↗
• InjuryAug 13, 2021Break; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE AND POTENTIALLY REMAINED IN THE JOINT.

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

  MAUDE report 12318552 ↗