BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D.4,5MM COMPRESSION SCREW L.32MM

    MDR report key: 22375069 · Received July 1, 2025

    Report

    Report Number
    3000931034-2025-00348
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 5, 2025
    Report Date
    September 10, 2025
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    03700386930164
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION IS COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE (VDV218) IS COMMERCIALLY AVAILABLE, CLEARED UNDER 510K NO. K030941.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. FROM THE PROVIDED PICTURE TAKEN JUST AFTER THE DEVICES EXPLANTATION (SOILED IMPLANTS), NO ADDITIONAL INFORMATION COULD BE OBSERVED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. 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. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY INCLUDING THE REMOVAL OF GLENOID IMPLANTS AND POLY LINER IN NEEDED DUE TO INFECTION. IT WAS ALSO REPORTED BY THE FACILITY THAT THE INFECTION HAD NOTHING TO DO WITH THE PRODUCT OR STERILITY OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY INCLUDING THE REMOVAL OF GLENOID IMPLANTS AND POLY LINER IN NEEDED DUE TO INFECTION. IT WAS ALSO REPORTED BY THE FACILITY THAT THE INFECTION HAD NOTHING TO DO WITH THE PRODUCT OR STERILITY OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418912 D.4,5MM COMPRESSION SCREW L.32MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. AF5908 03700386930164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention