BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1211270 · Received October 16, 2008

    Report

    Report Number
    1030489-2008-00574
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY TO IMPLANT ARTIFICIAL DISC, THE ANCHOR POST TIP WAS BROKEN OFF IN THE VERTEBRAL BODY OF C7. THE SURGEON DECIDED THAT HE COULD NOT REMOVE THE FRAGMENT WITHOUT DAMAGING THE VERTEBRAL BODY, SO IT WAS LEFT INSIDE THE PATIENT. THE SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ANCHOR POST LXH MEDTRONIC SOFAMOR DANEK NA IT06B013

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other