BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE VERTEBRAL BODY SPACER

    MDR report key: 1476364 · Received July 2, 2009

    Report

    Report Number
    1030489-2009-00604
    Event Type
    Malfunction
    Date Received
    July 2, 2009
    Date of Event
    June 2, 2009
    Report Date
    June 3, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    MAX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). 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; HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # W08F4311 AND 0010997W. 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 # 2991022, 510K # K073291 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH STENOSIS UNDERWENT A SPINAL PROCEDURE TO FUSE L4/S1 USING INTERBODY DEVICE AND POSTERIOR FIXATION. IT WAS REPORTED THAT THE DEVICE AT L5/S1 BACKED OUT. NO REVISION SURGERY IS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE VERTEBRAL BODY SPACER CAGE MAX WARSAW ORTHOPEDIC INC. NA W08F4311

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR CD HORIZON SPINAL SYSTEM SCREWS| ROD FOR POSTERIOR FIXATION