Biosteon ScrewRecalls & reported problems across all models

We found 8 models of Biosteon Screw by Biocomposites Ltd in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2018 and Sep 28, 2022 — classified as 30 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Biosteon Screw problems

Biosteon Screw models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Biosteon® Screw 234-010-161

  Screw, Fixation, Bone
  14 reports
• Biosteon® Screw 234-010-162

  Screw, Fixation, Bone
  4 reports
• Biosteon® Screw 234-010-163

  Screw, Fixation, Bone
  4 reports
• Biosteon® Screw 234-010-179

  Screw, Fixation, Bone
  4 reports
• Biosteon® Screw 234-010-164

  Screw, Fixation, Bone
  2 reports
• Biosteon® Screw 234-010-165

  Screw, Fixation, Bone
  2 reports
• Biosteon® Screw 234-010-166

  Screw, Fixation, Bone
  2 reports
• Biosteon® Screw 234-010-167

  Screw, Fixation, Bone
  1 report

Recent Biosteon Screw adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 28, 2022Break

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

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

  MAUDE report 15496220 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 4, 2022Break

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

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

  MAUDE report 14002191 ↗
• InjuryMar 17, 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 13792814 ↗
• InjuryJan 7, 2022Break; Material Integrity Problem; Material Integrity Problem

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

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

  MAUDE report 13195404 ↗
• InjuryJan 7, 2022Break; Material Integrity Problem; Material Integrity Problem

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

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

  MAUDE report 13192575 ↗
• InjuryDec 2, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE SCREW BROKE DURING THE PROCEDURE AND A PIECE POTENTIALLY REMAINED IN THE PATIENT.

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

  MAUDE report 12921048 ↗
• MalfunctionAug 30, 2021Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388947 ↗
• 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 ↗
• InjuryAug 12, 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 12316603 ↗
• InjuryAug 12, 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 12316602 ↗
• InjuryJun 17, 2021Material Integrity Problem; Break; Material Integrity Problem

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

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12018023 ↗