AXSOS 627610SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540685681), received between Jun 19, 2020 and Jul 2, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2026Fracture

  IT WAS REPORTED THAT THERE WAS A PLATE FAILURE THAT RESULTED IN A CONVERSION TO DFR.

  Patient problems: Insufficient Information

  MAUDE report 25689521 ↗
• InjuryOct 9, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "FRACTURE OF A FEMORAL PLATE 2 MONTHS AFTER SURGERY".

  Patient problems: Failure of Implant

  MAUDE report 17901236 ↗
• InjuryFeb 7, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE PATIENT COMPLAINS OF SUDDEN PAIN IN THE LEFT LOWER LIMB IN THE ABSENCE OF TRAUMA. ON (B)(6) 2023, AN X-RAY EXAMINATION REVEALED A NON-UNION OF THE SUPRACONDYLAR FRACTURE WITH BREAKAGE OF THE FIXATION DEVICE."

  Patient problems: Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16314865 ↗
• InjuryDec 12, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "AXSOS PLATE BROKEN 5 WEEKS AFTER MEDICAL PROCEDURE. FOLLOW-UP SURGERY WITH T2 SCN PLANNED."

  Patient problems: Failure of Implant

  MAUDE report 15963623 ↗
• InjuryJun 19, 2020Fracture; Fracture

  PHARMACIST REPORTED THAT: "PATIENT CONSULTING AT EMERGENCIES FOR PAIN AND CRACKING OF THE RIGHT FEMUR. OSTEOSYNTHESIS PLATE BROKEN SPONTANEOUSLY FOLLOWING MOBILIZATION OF THE PATIENT HAVING UNDERGONE A FIRST OSTEOSYNTHESIS ON (B)(6) 2019 ON A DISTAL LEFT FEMUR. PATIENT DIDN¿T FALL NOR SUFFER ANY TRAUMA SINCE THE FIRST PROCEDURE. OBSERVED CLINICAL CONSEQUENCES: RX: FRACTURE OF THE PLATE WITH DISPLACEMENT OF THE FRACTURE. TOTAL : BOTTOM THIRD LEFT FEMUR FRACTURE WITH PLATE BREAK PRECAUTIONARY MEASURES AND ACTION TAKEN: PLATE CHANGING URGENTLY IN THE OPERATING ROOM WITH A NEW PLATE AXSOS 3 AND FRACTURE CONSOLIDATION WITH BONE SUBSTITUTE." ADDITIONALLY REPORTED: THE PATIENT WAS WALKING WITH A CANE, ACCORDING TO THE SURGEON. THE SURGEON'S INSTRUCTIONS CONCERNING MOBILIZATION: NO SUPPORT FOR 4 WEEKS AFTER THE OPERATION AND RE-EDUCATION AFTER THE 4 WEEKS. SURGEON SAYS THE INSTRUCTIONS WERE FOLLOWED BY THE PATIENT. THERE ARE NO SPECIAL CIRCUMSTANCES OR PATHOLOGY IN THE PATIENT, HOWEVER THE SURGEON EXPRESSES DOUBT ABOUT A DELAY OR LACK OF CONSOLIDATION.

  Patient problems: Bone Fracture(s); Injury; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 10176299 ↗