BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM HYS SS 480MM ROD

    MDR report key: 931646 · Received October 24, 2007

    Report

    Report Number
    1526439-2007-00333
    Event Type
    Injury
    Date Received
    October 24, 2007
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K041119
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE AT THIS TIME. EVALUATION USING A SCANNING ELECTRON MICROSCOPE (SEM) FOUND THAT FRACTURES TO BE CONSISTENT WITH A FATIGUE FAILURE. THERE WAS NO MANUFACTURING OR MATERIAL DEFECTS DETECTED.

    Description of Event or Problem · 1

    CONTACT REPORTED THAT A PT, A DWARF WITH SCOLIOSIS EXPERIENCED POST-OP BREAKAGE OF SPINAL RODS. SCREWS AND RODS WERE PLACED FROM T4-S2. THE RODS BROKE AND A REVISION WAS PERFORMED. AS SURGICAL INTERVENTION OCCURRED AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM HYS SS 480MM ROD SPINAL FIXATION DEVICE KWP DEPUY SPINE, INC. NA UI052012R

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention