BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD

    MDR report key: 1833061 · Received September 13, 2010

    Report

    Report Number
    8010177-2010-00307
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 11, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K062498
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    A NURSE REPORTS VIA OUR SALES REP, THAT A RADIUS PLATE BROKE IN THE AREA OF THE LOWER SCREW ROW APPROX 6 WEEKS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD NA HRS STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other