BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MSD - UNKNOWN INSTRUMENT

    MDR report key: 1181713 · Received September 17, 2008

    Report

    Report Number
    1030489-2008-00511
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    August 18, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK MANUFACTURING
    Product Code
    JDN
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PT CORRESPONDENCE THAT THE PT UNDERWENT A CERVICAL LAMINOPLASTY AT C3-C7 USING METAL PLATE. IT WAS REPORTED THAT THE PLATE WAS BROKEN POST-OP. THE PT AND HER HUSBAND REPORTEDLY CONCERNED THAT "BLACK MARKET DEVICES" WAS USED IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MSD - UNKNOWN INSTRUMENT PLATE JDN MEDTRONIC SOFAMOR DANEK MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR