BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2147657 · Received July 1, 2011

    Report

    Report Number
    1030489-2011-00843
    Event Type
    Injury
    Date Received
    July 1, 2011
    Report Date
    October 24, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR PRODUCT EVALUATION. VISUAL REVIEW CONFIRMS ROD BROKEN. NO EVIDENCE OF ROD BEND OR MATERIAL GOUGE NEAR THE AREA OF FRACTURE INITIATION WHICH COULD PROMOTE PROPAGATION. MICROSCOPIC EXAMINATION REVEALS A FAIRLY FLAT, QUASI-BRITTLE FRACTURE WITH SOME EVIDENCE OF PROGRESSIVE STRIATIONS, INDICATIVE OF FATIGUE. FRACTURE SURFACE SUGGESTS A MULTI-MODAL FAILURE, WITH INITIAL SURFACE INDICATIVE OF OVERLOAD, SUBSEQUENTLY FOLLOWED BY A FLATTER SURFACE MORPHOLOGY WITH PROGRESSIVE STRIATIONS INDICATIVE OF CYCLIC FATIGUE UNTIL ULTIMATE FAILURE OF THE IMPLANT. DIMENSIONAL INSPECTION BOTH ABOVE AND BELOW THE FRACTURE SURFACE CONFIRMS ROD DIAMETER CONFORMS TO PRINT SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 855-011, 510K # K954645 WAS CLEARED IN THE UNITED STATES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLF AT L2/3 AND PEDICLE SUBTRACTION OSTEOTOMY AT L2. THE RODS WERE BROKEN BETWEEN L2 AND L3 AFTER THE SECONDARY SURGERY. THE REVISION SURGERY WAS PERFORMED APPROXIMATELY FOUR YEARS AFTER THE SECONDARY SURGERY TO REPLACE THE BROKEN RODS AND PLACE AN ANTERIOR FIXATION AT L1/4 FOR REINFORCEMENT. NO PATIENT COMPLICATIONS WERE REPORTED DURING AND AFTER THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA W06G1425

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PEDICLE SCREWS AND SET SCREWS