BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE VERTEBRAL BODY SPACER

    MDR report key: 1404142 · Received June 18, 2009

    Report

    Report Number
    1030489-2009-00570
    Event Type
    Injury
    Date Received
    June 18, 2009
    Date of Event
    May 29, 2009
    Report Date
    May 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

    DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. IMMEDIATE POST OP, 3 WEEKS POST OP, AND 3 MONTHS POST OP X-RAYS WERE REVIEWED. THE FILMS SHOW THE TITANIUM DEVICE AT L4-L5. A PLIF WAS DONE WITH POSTERIOR FIXATION. THE INTERBODY DEVICES WERE UNDERSIZED. THEY HAVE MIGRATED POSTERIORLY AT 3 WEEKS POST OP. THE DEVICES IN USE ARE LOT # W07B3327 AND W07D4132. 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 # 2990826, WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLIF, USING INTERBODY DEVICE AND POSTERIOR FIXATION AT L4/5. IT WAS REPORTED THAT ONE OF THE TWO IMPLANTED CAGE BACKED OUT. THE PATIENT REPORTEDLY HAD NUMBNESS POST OP. THE REVISION SURGERY WAS PERFORMED APPROXIMATELY 5 MONTHS POST OP IN 2009, AND THE PATIENT SYMPTOM WAS RESOLVED POST THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE VERTEBRAL BODY SPACER CAGE MAX WARSAW ORTHOPEDIC INC. NA W07B3327

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention