BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, LEF

    MDR report key: 2780631 · Received October 5, 2012

    Report

    Report Number
    8010177-2012-00220
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 13, 2012
    Manufacturer
    STRYKER LEIBINGER GMBH & CO. KG
    Product Code
    HRS
    PMA / PMN Number
    K040022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    THE HEAD NURSE OF THE HOSPITAL REPORTED THAT THE PLATE BROKE IN PT POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, LEF IMPLANT HRS STRYKER LEIBINGER GMBH & CO. KG NA 100007945

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR