AXSOS 627640Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613252579663), received between Jan 29, 2019 and Dec 18, 2025 — 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.

• InjuryDec 18, 2025Fracture; Fracture

  AS REPORTED: "THE SURGEON REMOVED A 10 HOLE PLATE THAT HAD BROKEN. IT WAS REPLACED WITH A DISTAL FEMUR 14 HOLE PLATE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23846011 ↗
• InjuryNov 24, 2025Fracture; Fracture

  THE CUSTOMER REPORTED: "PLATE FRACTURE 5 MONTHS AFTER IMPLANTATION. CLINICAL CONSEQUENCES AND CURRENT CONDITION OF THE PATIENT OR PERSON INVOLVED: REOPERATION OF THE FEMORAL SYNTHESIS. ACTIONS TAKEN FOR THE PATIENT WITH REGARD TO THE DEVICE: PATIENT NOTIFIED AND REOPERATED ON ACTIONS TAKEN IN THE ESTABLISHMENT: DMI RETAINED BY THE SURGEON".

  Patient problems: Insufficient Information

  MAUDE report 23632594 ↗
• InjuryOct 4, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD BEEN TREATED FOR PERIPROSTHETIC DISTAL FEMUR FRACTURES WITH PLATES. SOMETIME AFTER THE INSERTION OF THE PLATES, THE PATIENT CAME BACK INTO HOSPITAL WITH A BROKEN PLATE, WHICH WAS REMOVED AND REPLACED WITH IM NAIL.

  Patient problems: Failure of Implant

  MAUDE report 17873018 ↗
• InjuryMar 10, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED A PERI PROSTHETIC FRACTURE CASE. THE PATIENT HAD PREVIOUSLY HAD A FRACTURE PLATED WITH AN AXSOS DISTAL LATERAL FEMUR PLATE BUT THE PLATE HAS NOW BROKEN. THE PATIENT HAD TO BE REVISED.

  Patient problems: Failure of Implant; Limb Fracture

  MAUDE report 13727660 ↗
• InjuryJan 29, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT STRYKER PLATE BROKE IN HALF CAUSING EXCRUIATING PAIN AND A SECOND SURGERY. BECAUSE THIS PLATE BROKE ALMOST ONE YEAR TO THE DAY OF THE FIST SURGERY I LOST ANOTHER YEAR DUE TO ADDITIONAL SURGERY, WHEEL CHAIR BOUND, PHYSICAL THERAPY, DEPRESSION BECAUSE OF FAULTY PLATE.

  Patient problems: Ambulation or Postural Difficulties; Depression; Pain

  MAUDE report 8287411 ↗