BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE VERTEBRAL BODY SPACER

    MDR report key: 1367565 · Received April 17, 2009

    Report

    Report Number
    1030489-2009-00361
    Event Type
    Injury
    Date Received
    April 17, 2009
    Date of Event
    March 5, 2009
    Report Date
    March 5, 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 EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS 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#: 2990822, WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SPINAL PROCEDURE FOR STENOSIS AT L4/5/S1 USING CAGES AND POSTERIOR FIXATION. THE POSTERIOR FIXATION WAS AT RIGHT SIDE ONLY, AND THE CAGES WERE IMPLANTED AT L4/5 AND L5/S1. IT WAS REPORTED THAT THE CAGE BACKED OUT AT L5/S1 POST OP. THE PT REPORTEDLY RODE THE BICYCLE FOR REHABILITATION POST OP. THE REVISION SURGERY WAS PERFORMED APPROXIMATELY 12 WEEKS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE VERTEBRAL BODY SPACER CAGE MAX WARSAW ORTHOPEDIC INC. NA W07B2422

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention