AXSOS 627638Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252579656), received between Aug 7, 2018 and Aug 30, 2021 — classified as 2 injuries.

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.

• InjuryAug 30, 2021Fracture; Fracture

  THE CUSTOMER REPORTED THAT: "MRS P-MH RECEIVED AN AXSOS PLATE REF 627638 LOT D19852 ON (B)(6) 2020 FOLLOWING A SUPRA-CONDYLAR FEMUR FRACTURE DT.ON (B)(6) 2021, WHILE CLIMBING A STAIRCASE, THE PATIENT FELL AND FELT A CRACK.THE CT SCAN OF (B)(6) SHOWED A FRACTURE OF THE FEMORAL PLATE AND A 2 CM SHORTENING OF THE FEMUR WITH AN ENGAGED FRACTURE.THE PATIENT WAS OPERATED ON AGAIN ON 04.08: REMOVAL OF THE PLATE AND A NEW OSTEOSYNTHESIS BY PLATE AND GRAFT DECORTICATION."

  Patient problems: Failure of Implant; Limb Fracture; Unequal Limb Length

  MAUDE report 12385645 ↗
• InjuryAug 7, 2018Break; Difficult to Remove; Material Protrusion/Extrusion

  THIS PI IS FOR REMOVAL OF THREE SCREWS AND SCREWDRIVER BREAKAGE. ONE SCREW WAS PROTRUDING THROUGH (I.E. BREAKING) PATIENTS' SKIN IN A PLATE/ SCREW CONSTRUCT. THE FIRST SCREW STRIPPED AND REMAINED IN PATIENT, SECOND SCREW REMOVED WITHOUT INCIDENT. THE SHAFT OF THE SCREWDRIVER BROKE WHEN ATTEMPTING TO REMOVE THE THIRD SCREW. PATIENT'S BONE QUALITY UNKNOWN. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Device Embedded In Tissue or Plaque; Tissue Damage

  MAUDE report 7756194 ↗