OsteoBridge™ IKA Knee Arthrodesis 10° Spacer 40 50Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048266078735), received between Jul 30, 2018 and May 4, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K101939); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2022Migration or Expulsion of Device

  THE PATIENT HAVE HAD IMPLANTED AN IKA SYSTEM. THE SPACER OF THE SYSTEM SEEMS TO BE ROTATED ABOUT 90°. IT WAS DIAGNOSED IN (B)(6) 2017. THE SYSTEM WAS VERY WELL IMPLANTED AND ALTHOUGH IT WAS ROTATED IT WORKED SUFFICIENT SO FAR THAT THE SURGEON DECIDES TO HAVE A CLOSE FOLLOW-UP AND WAIT TO REVISE THE SYSTEM. THE PATIENT HAVE HAD NO PAIN AND WALKED WELL WITH THE ROTATED SYSTEM. IN (B)(6) 2018 THE SURGEON DECIDED TO REMOVE THE SYSTEM TO AVOID A PERMANENT INAPPROPRIATE LOAD. DURING REVISION THE NAILS HAVE SHOWN TO BE INGROWN WELL SO THAT THE SURGEON DECIDED TO JUST CHANGE THE SPACER.

  Patient problems: Failure of Implant

  MAUDE report 14274287 ↗
• MalfunctionJul 30, 2018Unintended Movement

  THE PATIENT HAVE HAD IMPLANTED AN IKA SYSTEM. THE SPACER OF THE SYSTEM SEEMS TO BE ROTATED ABOUT 90°. IT WAS DIAGNOSED IN (B)(6) 2017. THE SYSTEM WAS VERY WELL IMPLANTED AND ALTHOUGH IT WAS ROTATED IT WORKED SUFFICIENT SO FAR THAT THE SURGEON DECIDES TO HAVE A CLOSE FOLLOW-UP AND WAIT TO REVISE THE SYSTEM. THE PATIENT HAVE HAD NO PAIN AND WALKED WELL WITH THE ROTATED SYSTEM. IN (B)(6) 2018 THE SURGEON DECIDED TO REMOVE THE SYSTEM TO AVOID A PERMANENT INAPPROPRIATE LOAD. DURING REVISION THE NAILS HAVE SHOWN TO BE INGROWN WELL SO THAT THE SURGEON DECIDED TO JUST CHANGE THE SPACER.

  Patient problems: No Code Available

  MAUDE report 7731138 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101939. One submission often covers many models, so check the product and lot details in each record.

• Z-0435-2021 · Sep 18, 2020 · Terminated
  OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails