BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE VERTEBRAL BODY SPACER

    MDR report key: 1445372 · Received August 20, 2009

    Report

    Report Number
    1030489-2009-00781
    Event Type
    Injury
    Date Received
    August 20, 2009
    Report Date
    July 22, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    MAX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. THE SUSPECT DEVICES IN USE ARE LOT # W08A1033 AND W08E3789. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG #2991026, WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A TLIF FOR BILATERAL FIXATION AT L2/3/4 USING CAGE AND POSTERIOR FIXATION. IT WAS REPORTED THAT THE CAGE IMPLANTED IN L3/4 BACKED OUT. THE SURGEON BELIEVED THAT THE SIZE OF THE CAGE MIGHT BE SMALL. THE REVISION SURGERY WAS PERFORMED APPROX 18 DAYS POST OP TO REPLACE THE CAGE TO THE LARGER SIZED CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE VERTEBRAL BODY SPACER CAGE MAX WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention