ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS OS327524Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055662909449), received between Jan 17, 2020 and Jan 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K111678); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE FOR THE FUSION OF THE 1ST MTPJ, THE SCREW BROKE OFF BEFORE THE AT HEAD ENTERED THE PLATE AT THE MEDIAL PROXIMAL SCREW HOLE. THE DISTAL PORTION OF THE SCREW REMAINS IN THE PATIENT AS IT WAS IRRETRIEVABLE, AND THE PROXIMAL PORTION OF THE SCREW HAS BEEN RETURNED. PATIENT BONE QUALITY IS UNKNOWN. IT WAS REPORTED THAT A LAPIDUS LOCKING PLATE WAS USED WITH THE COMPLAINT DEVICE, WHICH IS NOT COMPATIBLE WITH ANY FPS 2.7MM SCREW. THE SURGICAL PROCEDURE CONSISTED OF INITIAL INSERTION OF A 3.5MM CANNULATED COMPRESSION SCREW PLANTARLY, FOLLOWED BY FIXATION OF THE PLATE BY PARTIAL INSERTION OF THE LOCKING SCREWS. THE PROXIMAL SCREWS WERE INSERTED PRIOR TO THE DISTAL, BUT NOT FULLY LOCKED INTO THE PLATE. UPON TIGHTENING OF THE THIRD SCREW AT THE DISTAL END THE SCREW FRACTURED PRIOR TO LOCKING INTO THE PLATE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9600383 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111678. One submission often covers many models, so check the product and lot details in each record.

• Z-2835-2016 · Jul 21, 2016 · Terminated
  FPS 35mm x 3.5 mm non-locking screw