BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 8621360 · Received May 17, 2019

    Report

    Report Number
    0008031020-2019-00503
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    April 25, 2019
    Report Date
    May 17, 2019
    Manufacturer
    STRYKER GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION SUCH AS THE PATIENT ACTIVITY LEVEL POST-OP, THE PATIENT DATA, THE X-RAYS, AS WELL AS THE CATALOG AND LOT NUMBER OF THE DEVICES ARE NECESSARY IN ORDER TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. DISPOSED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT ANKLE WAS REVISED DUE TO 2 OF THE SYNDESMOTIC SCREWS BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415287 UNKNOWN SCREW IMPLANT HWC STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention