BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE VERTEBRAL BODY SPACER

    MDR report key: 1402841 · Received June 11, 2009

    Report

    Report Number
    1030489-2009-00493
    Event Type
    Injury
    Date Received
    June 11, 2009
    Date of Event
    May 1, 2009
    Report Date
    May 1, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    MQP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    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 # 2991026, WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TLIF FOR SPONDYLOLISTHESIS AT L4/5 USING INTERBODY DEVICE AND POSTERIOR FIXATION. IT WAS REPORTED THAT THE PATIENT HAD A FALL WHILE EXERCISING POST OP. IT WAS FOUND THAT THE INTERBODY DEVICE BACKED OUT AT UNKNOWN TIME POST OP. THE REVISION SURGERY WAS PERFORMED APPROXIMATELY THREE WEEKS POST OP TO REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE VERTEBRAL BODY SPACER CAGE MQP WARSAW ORTHOPEDIC INC. NA W08E3789

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention