BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSS MIAMI 4.0 ROD, 48MM

    MDR report key: 1230221 · Received November 13, 2008

    Report

    Report Number
    1526439-2008-00189
    Event Type
    Injury
    Date Received
    November 13, 2008
    Manufacturer
    DEPUY SPINE INC.
    Product Code
    KWP
    PMA / PMN Number
    K962628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF X-RAYS CONFIRMED THE REPORTED EVENT. THE CONSTRUCT CONSISTED OF A SINGLE ROD FIXED AT EACH END. IMAGES INDICATE THAT THIS WAS A CHALLENGING CASE. NO CONCLUSIONS CAN BE MADE AT THIS TIME. BREAKAGE IS LISTED AS A POSSIBLE ADVERSE EVENT IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE.

    Description of Event or Problem · 1

    PATIENT WITH CONGENITAL MALFORMATION, MULTIPLE BONE DYSPLASIA METAFISARIA WAS IMPLANTED WITH MOSS MIAMI ROD IN 2007. APPROX. 1-YEAR POST-OP, THE PATIENT REPORTED BACK PAIN. X-RAYS CONFIRMED BREAKAGE OF THE ROD. SURGEON PLANNED TO REVISE THE CASE. AS SURGICAL INTERVENTION SHALL OCCUR, AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSS MIAMI 4.0 ROD, 48MM FIXATION DEVICE KWP DEPUY SPINE INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention