OsteoBridge™ IDSF Diaphysis Femoral Nail 12 130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048266179623), received between Oct 15, 2020 and May 4, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K181026); 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, 2022Inaccurate Information; Inaccurate Information

  DURING A SURGERY A MISLABELED OSTEOBRIDGE IDSF FEMORAL NAIL HAS BEEN IDENTIFIED. THE SURGEON WANTED TO IMPLANT A FEMORAL IDSF SYSTEM. AFTER CEMENTED IMPLANTATION OF THE NAILS HE RECOGNIZED THAT THE CLAMPING DIAMETER OF ONE NAIL WAS 14 MM INSTEAD OF 16 MM (FEMORAL IDSF NAILS HAVE 16 MM). THIS LED TOT HE CIRCUMSTANCE THAT THE SPACER WHICH SHALL CONNECT THE NAILS DID NOT FIT. THEREFORE THE SURGEON THEREFORE DECIDED TO USE A TEMPORARY IMPLANT AROUND 14MM CLAMPING AREA OF NAIL TO PROTECT NAIL END. AN IDSF SPACER PROVISIONALLY CLAMPED ONTO CONSTRUCT TO MANAGE LENGTH OF EXTREMITY. PATIENT/ SURGEON HAVE BEEN BE PROVIDED WITH A CUSTOM MADE DEVICE FOR FINAL SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 14274375 ↗
• MalfunctionOct 15, 2020Device Markings/Labelling Problem

  DURING A SURGERY A MISLABELED OSTEOBRIDGE IDSF FEMORAL NAIL HAS BEEN IDENTIFIED. THE SURGEON WANTED TO IMPLANT A FEMORAL IDSF SYSTEM. AFTER CEMENTED IMPLANTATION OF THE NAILS HE RECOGNIZED THAT THE CLAMPING DIAMETER OF ONE NAIL WAS 14 MM INSTEAD OF 16 MM (FEMORAL IDSF NAILS HAVE 16 MM). THIS LED TOT HE CIRCUMSTANCE THAT THE SPACER WHICH SHALL CONNECT THE NAILS DID NOT FIT. THEREFORE, THE SURGEON THEREFORE DECIDED TO USE A TEMPORARY IMPLANT AROUND 14MM CLAMPING AREA OF NAIL TO PROTECT NAIL END. AN IDSF SPACER PROVISIONALLY CLAMPED ONTO CONSTRUCT TO MANAGE LENGTH OF EXTREMITY. PATIENT/ SURGEON HAVE BEEN BE PROVIDED WITH A CUSTOM MADE DEVICE FOR FINAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10682314 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181026. One submission often covers many models, so check the product and lot details in each record.

• Z-0437-2021 · Sep 18, 2020 · Terminated
  OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
• Z-0436-2021 · Sep 18, 2020 · Terminated
  OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
• Z-0438-2021 · Sep 18, 2020 · Terminated
  OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)