BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5928267 · Received September 6, 2016

    Report

    Report Number
    1030489-2016-02479
    Event Type
    Injury
    Date Received
    September 6, 2016
    Report Date
    September 20, 2016
    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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG #1475006120, 510K # K121680 WAS CLEARED IN THE UNITED STATES. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL REVIEW CONFIRMS ROD BROKEN. FRACTURE SURFACE DAMAGE AND SMEARING NOTED. MULTIPLE WITNESS MARKS NOTED ON ROD. NO SURFACE DEFECT IDENTIFIED ADJACENT TO THE INITIAL CRACK PROPAGATION AREA THAT COULD CONTRIBUTE TO CRACK INITIATION AND PROPAGATION. EXAMINATION OF THE FRACTURE SURFACE OVERLOAD, AS EVIDENCED BY THE RAYS EMANATING FROM A SINGLE ORIGINATION POINT, FOLLOWED BY SOME EVIDENCE OF PROGRESSIVE CONVEX STRIATIONS RUNNING THROUGH APPROXIMATELY 50% OF THE WAY THROUGH THE CROSS-SECTIONAL AREA. THIS SECTION FOLLOWED BY ANOTHER REGION OF INCREASED MATERIAL DISRUPTION, WHICH APPEARS TO HAVE SUBSEQUENTLY RESULTED IN ULTIMATE FAILURE OF THE IMPLANT. ROD CHEMICAL, MECHANICAL, HARDNESS, AND GRAIN STRUCTURE PROPERTIES VERIFIED BY INDEPENDENT 3RD PARTY INSPECTION. DIMENSIONAL INSPECTION CONFIRMS ROD DIAMETER TO BE WITHIN PRINT SPECIFICATION. AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANTS; UNABLE TO DEFINITIVELY DETERMINE SPECIFIC ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION, DUE TO EVIDENCE WHICH COULD SUPPORT MULTIPLE CONCLUSIONS. X-RAY ANALYSIS: "POST-OP AP/ LATERAL X-RAYS PROVIDED FROM L3-S1 POSTERIOR SPINAL FUSION. ONE OF THE RODS IS FRACTURED BETWEEN L4-5; UNABLE TO ACCESS FUSION STATUS ON THESE X-RAYS. PATIENT APPEARS TO HAVE LOST LUMBAR LORDOSIS AND HAVE A FLAT BACK. UNABLE TO ACCESS CORONAL AND SAGITTAL BALANCE AS A POSSIBLE CONTRIBUTING FACTOR. ROOT CAUSE: INDETERMINATE."

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION SURGERY AT L3-S1 LEVELS, FOR THE TREATMENT OF L4 COMPRESSION FRACTURE AND L5 BURST FRACTURE. ON AN UNKNOWN DATE, POST-OP, ROD AT L4/5 BROKE (LEFT SIDE). REVISION SURGERY WAS PERFORMED FOR EXPLANTING THE BROKEN ROD. NO FRAGMENTS OF THE PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579740 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0242149W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention