BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLORADO 2 SPINAL SYSTEM

    MDR report key: 2466286 · Received February 23, 2012

    Report

    Report Number
    1030489-2012-00195
    Event Type
    Injury
    Date Received
    February 23, 2012
    Report Date
    January 24, 2012
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE PART# G8634111 , LOT 0060242W, EXPIRATION DATE 11/06/2017; LOT 0102208W, EXPIRATION DATE 07-07-2018. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8634111, 510K # K052054 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT 0060242W IS (B)(4) 2009; THE MANUFACTURE DATE FOR LOT 0102208W IS (B)(4) 2010. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS 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 PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FIXATION AT L1-S2 TO TREAT DEGENERATIVE KYPHOSCOLIOSIS. IT WAS DISCOVERED THAT ONE OF THE NUTS ON THE SACRAL PLATE HAD MIGRATED AND ALLOWED THE PLATE AND ITS CONNECTOR TO BACK OUT. THE PATIENT COMPLAINED OF PAIN. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. NO REVISION SURGERY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLORADO 2 SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Other PLATE, CONNECTOR