BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW AXSOS 3 TI 4.0MM / L36MM

    MDR report key: 7899270 · Received September 21, 2018

    Report

    Report Number
    0008031020-2018-00627
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    July 9, 2018
    Report Date
    September 21, 2018
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    UDI-DI
    07613252579830
    PMA / PMN Number
    K123964
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WAS DISPOSED.

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED WITH AN AXSOS PHL PLATE ON (B)(6) 2018. THE PATIENT COMPLAINED OF PAIN DURING HER FOLLOW-UP VISIT ON (B)(6) 2018. SCREWS OF THE PLATE HAD EMIGRATED. THE PATIENT HAD TO BE OPERATED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740802 LOCKING SCREW AXSOS 3 TI 4.0MM / L36MM PLATE, FIXATION, BONE HRS STRYKER GMBH UNKNOWN 07613252579830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention