BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALVEOLAR RIDGE DISTRATOR PLATE

    MDR report key: 384351 · Received March 22, 2002

    Report

    Report Number
    1032347-2002-00005
    Event Type
    Other
    Date Received
    March 22, 2002
    Report Date
    March 20, 2002
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Product Code
    MQN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DR. PLACED DISTRACTION DEVICE IN PT. AFTER LATENCY, THE PT WAS INSTRUCTED TO CONTINUE DISTRACTION. THE PT CAME BACK IN A FEW DAYS AND ADVISED THAT THE PIN FELL OUT OF THE DISTRACTOR DURING DISTRACTION. REVISION SURGERY PERFORMED 3/2002 TO REMOVE THE DEVICE AND PLACE A BONE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALVEOLAR RIDGE DISTRATOR PLATE * MQN WALTER LORENZ SURGICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other