Distal Femoral Osteotomy System (DFOS) 01-1050-0032Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841132122884), received between Feb 18, 2020 and May 14, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2020Fracture; Fracture

  IT HAS BEEN REPORTED THAT DURING THE PLACEMENT OF A LOCKING CANNULATED BLADE PLATE, A DRILL BIT FRACTURED. NO PIECES OF THE DRILL BIT REMAINED IN THE PATIENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10059436 ↗
• MalfunctionApr 30, 2020Fracture; Fracture

  IT HAS BEEN REPORTED THAT DURING THE PLACEMENT OF A LOCKING CANNULATED BLADE PLATE, A DRILL BIT FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10014034 ↗
• InjuryFeb 18, 2020Fracture; Fracture

  IT HAS BEEN REPORTED THAT DURING THE PLACEMENT OF A LOCKING CANNULATED BLADE PLATE, A DRILL BIT FRACTURED. THE FRACTURED PORTION OF THE DRILL BIT REMAINS IN THE PATIENT'S BONE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9720753 ↗