AXSOS 627608Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252579564), received between Dec 21, 2021 and Nov 1, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2023Break; Fracture; Adverse Event Without Identified Device or Use Problem; Break; Fracture; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE PATIENT HAD A NON UNION ROUGHLY 1 YEAR FROM ORIF SURGERY. THE PATIENT WAS REVISED WITH A NON UNION TAKE DOWN AND HAD A NAIL/PLATE COMBO FOR TREATMENT DURING THE REVISION SURGERY.". UPDATE: X-RAYS SHOW THAT THE PLATE WAS BROKEN.

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

  MAUDE report 18048623 ↗
• InjuryJun 27, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THE PATIENT'S LEFT DISTAL FEMUR WAS REVISED DUE TO A BROKEN PLATE. PATIENT WAS REVISED TO A RETROGRADE NAIL. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17213493 ↗
• InjuryDec 21, 2021Break; Break

  THE FOLLOWING EVENT WAS REPORTED: THE PATIENT WAS (B)(6) YEARS OLD AT THE TIME OF HER INJURIES. ON (B)(6) 2018, SHE LOST HER FOOTING AND FELL DOWN 12 CONCRETE STEPS WHILE LEAVING CHURCH, TUMBLING FORWARD HEAD OVER HEELS. AS A RESULT, SHE SUFFERED A NUMBER OF INJURIES, THE MOST SIGNIFICANT BEING A CLOSED FRACTURE OF THE LEFT DISTAL FEMUR. ON (B)(6) 2018, SHE UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY OF HER LEFT FEMUR AT SPARROW HOSPITAL AND RECEIVED A STRYKER 8-HOLE LEFT DISTAL FEMUR PLATE AS WELL AS 3.5 MM LAG CORTICAL SCREWS. ON (B)(6) 2019, SHE WAS TAKEN BY HER SON TO SPARROW HOSPITAL EMERGENCY DEPARTMENT, BECAUSE THE PAIN IN HER LEG HAD BECOME UNBEARABLE AND SHE WAS UNABLE TO EVEN WALK. IMPORTANTLY, THERE WAS NO TRAUMA OR INCITING EVENTS TO PROVOKE THE LEG PAIN. A REVIEW OF THE PATIENT'S X-RAY SHOWED NOT ONLY A POORLY HEALED FEMUR FRACTURE, BUT ALSO A FRACTURE OF THE STRYKER ORTHOPEDIC PLATE. THE PLATE APPEARED TO BE FRACTURED AT THE LEVEL OF THE FOURTH PROXIMAL SCREW. SHE WAS INITIALLY ADMITTED FOR PAIN CONTROL AND FURTHER EVALUATION, AND SHE WAS GIVEN MORPHINE, NORCO AND TYLENOL FOR THE UNCONTROLLED PAIN. ON (B)(6) 2019, THE PATIENT UNDERWENT A SECOND SURGERY TO HER L

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain

  MAUDE report 13056651 ↗