BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 FOR RIGHT TIBIA 14 HOLE / L229MM

    MDR report key: 23988982 · Received January 7, 2026

    Report

    Report Number
    0008031020-2026-00010
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    December 11, 2025
    Report Date
    April 13, 2026
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    UDI-DI
    07613327082111
    PMA / PMN Number
    K222381
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED SINCE THE DEVICE WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE. THE RECEIVED PLATE WAS FOUND TO BE BROKEN AROUND MIDDLE AT THE LEVEL OF 6TH ROUND HOLE FROM THE OBLONG HOLE. THE NATURE OF BREAKAGE EXHIBITS TYPICAL CHARACTERISTICS OF A FATIGUE FAILURE WITH SIGNIFICANT PLASTIC DEFORMATION MAJORLY ALONG THE EDGES AND MOSTLY ON THE INSTANTANEOUS FRACTURE ZONE. FATIGUE FRACTURE CAN BE CLEARLY DISTINGUISHED WITH THE PRESENCE OF LINES OF REST, TRAVERSING FROM THE LATERAL SIDE TOWARDS THE MEDIAL. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. A FEW X-RAYS THAT WERE PROVIDED WERE PRESENTED TO OUR HCP WHO OPINED THAT IT IS CLEARLY A VERY COMPLEX HIGH ENERGY TRAUMA, WHERE THE BODY DID TRY TO GET THE FRACTURE TO HEAL. BUT UNFORTUNATELY FOR THE PATIENT THE HEALING WAS NOT FAST ENOUGH. IT IS A CASE OF A HYPERTROPHIC NON-UNION OF THE PROXIMAL PART OF THE FRACTURE, THIS CONTRIBUTED TO THE FAILURE OF THE IMPLANT. THE LOCATION AND PATTERN OF THE FRACTURE, BIOLOGY, AND THE TECHNICAL ASPECTS OF THE SURGICAL PROCEDURE HAVE CONTRIBUTED TO THE EVENT. FURTHERMORE, PATIENT ACTIVITY LEVELS POST-OP MAY ALSO HAVE CONTRIBUTED TO AN INADEQUATE LOAD DISTRIBUTION AND, THEREFORE, THE BREAKAGE OF THE IMPLANT. THE IFU CLEARLY INSTRUCTS THE USER THAT: THE IMPLANT IS INTENDED FOR TEMPORARY BONE FIXATION. IN THE EVENT OF A DELAY IN BONE CONSOLIDATION, OR IF SUCH CONSOLIDATION DOES NOT TAKE PLACE, OR IF EXPLANTATION IS NOT CARRIED OUT, COMPLICATIONS MAY OCCUR, FOR EXAMPLE FRACTURE OR LOOSENING OF THE IMPLANT OR INSTABILITY OF THE IMPLANT SYSTEM. THE SURGEON MUST WARN PATIENT THAT THE DEVICE CANNOT AND DOES NOT REPLICATE A NORMAL HEALTHY BONE, THAT THE DEVICE CAN BREAK OR BECOME DAMAGED AS A RESULT OF STRENUOUS ACTIVITY, TRAUMA, MAL-UNION OR NONUNION AND THAT THE DEVICE HAS A FINITE EXPECTED SERVICE LIFE AND MAY NEED TO BE REMOVED AT SOME TIME IN THE FUTURE. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    AS REPORTED: "PATIENT WHO UNDERWENT ORIF FOR A TIBIAL FRACTURE ON (B)(6) 2025. THE PATIENT EXPERIENCED PAIN. X-RAY EXAMINATION CONFIRMED FRACTURE OF THE PLATE. THE REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025."

    Description of Event or Problem · 0

    AS REPORTED: "PATIENT WHO UNDERWENT ORIF FOR A TIBIAL FRACTURE ON (B)(6) 2025.THE PATIENT EXPERIENCED PAIN. X-RAY EXAMINATION CONFIRMED FRACTURE OF THE PLATE.THE REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285691 DISTAL ANTEROLATERAL TIBIA PLATE AXSOS 3 FOR RIGHT TIBIA 14 HOLE / L229MM PLATE, FIXATION, BONE HRS STRYKER GMBH AF5717 07613327082111

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention