AXSOS 703522Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540693600), received between Mar 12, 2020 and Oct 25, 2024 — classified as 1 injury, 1 malfunction.

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

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 16, 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.

• InjuryOct 25, 2024Break; Fracture; Break; Fracture

  AS REPORTED BY REP: "CASE TYPE: RIGHT DISTAL FEMORAL PERIPROSTHETIC FRACTURE. PRH-TELFORD HAD ITEM: 703522 (PLATE ADAPTER / DIST LAT RIGHT) BREAK.". FURTHER INFORMATION FROM REP ON 09/27/2024: "WHEN ATTACHING ADAPTOR TO PLATE, ONE OF THE ¿TEETH¿ HAD SHEARED OFF RENDERING THE DEVICE UNSTABLE AND THEREFORE UNUSABLE. ATTEMPTED MINIMALLY INVASIVE TECHNIQUE IN COMPROMISED PATIENT; HOWEVER, ONCE THE ADAPTOR BROKE, THE SURGEON HAD TO MAKE A LARGE INCISION TO ATTACH THE PLATE TO THE BONE. DEBRIS REPORTED. INSTRUMENT BROKE AWAY FROM THE PATIENT. LARGE WOUND IN COMPROMISED PATIENT.

  Patient problems: Perforation

  MAUDE report 20536863 ↗
• MalfunctionMar 12, 2020Material Deformation; Material Deformation

  REP LEFT A VOICEMAIL SAYING THE THREADS OF THE DEVICES STRIPPED INTRA-OPERATIVELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9827488 ↗