BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 2430020 · Received January 27, 2012

    Report

    Report Number
    1030489-2012-00087
    Event Type
    Injury
    Date Received
    January 27, 2012
    Date of Event
    December 27, 2011
    Report Date
    December 28, 2011
    Manufacturer
    WARSAW ORTHOPEDICS
    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

    FILMS WERE SUPPLIED FOR REVIEW. PEDICLE SCREW CONSTRUCT L1-L2-L3-L4. LATERAL VIEW SHOWS RIGHT L1 SCREW DISCONNECTED FROM LATERAL CONNECTOR. INTRAOPERATIVE PHOTOS ALSO VERIFY DISASSOCIATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8379120C, 510K # K011029 WAS CLEARED IN THE UNITED STATES. 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 NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR PROCEDURE AT L1-4 TO TREAT SPINAL CANAL STENOSIS. IT WAS FOUND 21 DAYS POST-OP THAT L1 CONNECTOR HAD MIGRATED. THE PATIENT UNDERWENT REVISION SURGERY 1 MONTH POST OP. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    AFTER HARDWARE REMOVAL, NEW HARDWARE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0160782W

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention RODS