BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE VERTEBRAL BODY SPACER

    MDR report key: 1439810 · Received August 6, 2009

    Report

    Report Number
    1030489-2009-00738
    Event Type
    Injury
    Date Received
    August 6, 2009
    Report Date
    July 9, 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 PATIENT UNDERWENT A TLIF TO IMPLANT THE INTERBODY DEVICE AT L4/5. THE CAGE REPORTEDLY BACKED OUT POST OP. THE SURGEON BELIEVED THAT THE SIZE OF THE CAGE MAY HAVE BEEN TOO SMALL. THE REVISION SURGERY WAS PERFORMED APPROXIMATELY A MONTH POST OP TO REPLACE THE CAGE. THE PATIENT REPORTEDLY WAS DOING WELL AFTER THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE VERTEBRAL BODY SPACER CAGE MAX WARSAW ORTHOPEDIC INC. NA W07G3429

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention