BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MEDTRONIC PRODUCT

    MDR report key: 1894893 · Received November 4, 2010

    Report

    Report Number
    1030489-2010-01442
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    July 14, 2010
    Report Date
    October 6, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWQ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MINI-OPEN TLIF AT L4-L5 USING POSTERIOR FIXATION. POST-OP, THE PATIENT HAD PARESIS OF M QUADRICEPS ON THE RIGHT, AND LEFT L4 RADICULOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK MEDTRONIC PRODUCT UNK KWQ MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention EXPLANTED:| IMPLANTED:| CD HORIZON SPINAL SYSTEM| IMPLANTED:| EXPLANTED:| METRX X-TUBE