BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 1576878 · Received December 21, 2009

    Report

    Report Number
    1030489-2009-01182
    Event Type
    Malfunction
    Date Received
    December 21, 2009
    Report Date
    November 24, 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

    (B) (4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 2991226, 510K # K073291 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A PLF AT L5/S1 IMPLANTING INTERBODY DEVICES AND POSTERIOR FIXATION. THE POST OP X-RAYS SHOWED THAT THE CAGES BACKED HALF WAY OUT. THE PT COMPLAINED OF PAIN. THE REVISION SURGERY WAS PERFORMED APPROXIMATELY ONE MONTH POST OP TO REPLACE THE CAGES. AT THE REVISION SURGERY, ADDITIONAL SACRAL PLATE WAS IMPLANTED AT S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE SPINAL SYSTEM CAGE MAX WARSAW ORTHOPEDIC INC. NA W08G0228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention