BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLATE WRIST ARTHRODESIS SYSTEM

    MDR report key: 3528326 · Received December 10, 2013

    Report

    Report Number
    3006742481-2013-00008
    Event Type
    Other
    Date Received
    December 10, 2013
    Date of Event
    November 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    SKELETAL DYNAMICS LLC
    Product Code
    KWI
    PMA / PMN Number
    K092720
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF EVENT. REVIEW OF MANUFACTURING RECORDS DEMONSTRATES THAT ALL MATERIALS MET RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLATE NAIL WAS REMOVED. THE CONNECTOR WAS NOT ATTACHED TO THE NAIL ALLOWING THE NAIL TO MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645368 IMPLATE WRIST ARTHRODESIS SYSTEM NONE KWI SKELETAL DYNAMICS LLC AZ1210001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other