BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 3735448 · Received April 9, 2014

    Report

    Report Number
    1030489-2014-02118
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    February 1, 2014
    Report Date
    March 11, 2014
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    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 # 828-083, 510K # K880215 WAS CLEARED IN THE UNITED STATES. THE DEVICE WAS NOT RETURNED FOR EVALUATION HOWEVER FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: THIS CASE REPRESENTS A KYPHOSCOLIOSIS FUSION FROM T10 TO THE ILIAC CREST. PLIF WAS PERFORMED THROUGH L2 TO THE ILIAC CREST WITH A COMPETITORS LATERAL CONNECTORS. IT WAS FOUND THAT THE RODS HAD BROKEN THROUGH THE L5/S1 INTERSPACE, AND THIS IS SEEN ON 6 FILMS. POSITION OF SCREWS, RODS, LATERAL CONNECTORS AND CROSS LINKS APPEAR ADEQUATE. BROKEN RODS HAVE NOT MIGRATED A SIGNIFICANT DISTANCE. FAILURE THROUGH L5/S1 IS THE MOST COMMON LEVEL DESPITE APPROPRIATE ANTERIOR COLUMN SUPPORT.

    Additional Manufacturer Narrative · 1

    VISUAL REVIEW CONFIRMS ROD BROKEN. MULTIPLE WITNESS MARKS NOTED ON ROD. NO SURFACE DEFECT NOTED ADJACENT TO THE INITIAL CRACK PROPAGATION AREA THAT COULD CONTRIBUTE TO CRACK INITIATION AND PROPAGATION IDENTIFIED. EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED MULTIMODAL FRACTURES, WITH INITIAL REGION WITH EVIDENCE OF PROGRESSIVE CONVEX STRIATIONS (BEACH MARKS) APPROXIMATELY 40% OF THE WAY THROUGH THE CROSS-SECTIONAL AREA, FOLLOWED BY ANOTHER REGION OF INCREASED MATERIAL DISRUPTION, RIVERLINES, AND SHEAR LIP, WHICH ARE CONSISTENT WITH OVERLOAD WHICH APPEARS TO HAVE RESULTED IN ULTIMATE FAILURE OF THE IMPLANT. DIMENSIONAL INSPECTION CONFIRMS ROD DIAMETER BOTH ABOVE AND BELOW THE FRACTURE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT T10-ILIAC TO TREAT KYPHOSCOLIOSIS. APPROXIMATELY ONE YEAR POST-OP IT WAS FOUND THAT THE RODS WERE BROKEN ON BOTH SIDES OF THE CONSTRUCT. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE BROKEN RODS AND THE CONSTRUCT WAS REINFORCED WITH 4 RODS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213782 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA 0119999W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS