BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE VERTEBRAL BODY SPACER

    MDR report key: 1510201 · Received October 1, 2009

    Report

    Report Number
    1030489-2009-00907
    Event Type
    Malfunction
    Date Received
    October 1, 2009
    Report Date
    September 8, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    MQP
    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 MFR 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 # 2990826, 510K # K073291 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WHO HAD DISC HERNIATION UNDERWENT A TLIF AT L4/5 USING CAGE AND POSTERIOR FIXATION. IT WAS REPORTED THAT ONE MONTH POST OP, THE CAGE BACKED OUT ABOUT ONE THIRD FROM ITS ORIGINAL POSITION. THE PT DID NOT COMPLAIN OF PAIN AT THIS TIME. THE REVISION SURGERY REPORTEDLY WILL BE PERFORMED ON (B) (6) 2009, TO REPLACE THE CAGE WITH A LARGER SIZED CAGE AND MAYBE ADD MORE COMPRESSION. THE SURGEON COMMENTED THAT THE SIZE OF THE CAGE THAT HE IMPLANTED MAY HAVE BEEN TOO SMALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE VERTEBRAL BODY SPACER CAGE MQP WARSAW ORTHOPEDIC INC. NA W07D4140

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention