BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 3804825 · Received May 12, 2014

    Report

    Report Number
    1030489-2014-02496
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 14, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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: 3 AP VIEWS AND 2 LATERAL VIEWS OF SCOLIOSIS CONSTRUCT ARE REVIEWED. ALL VIEWS VERIFY A BROKEN ROD ABOVE THE CROSSLINK BETWEEN L5 AND S1 SCREWS. THIS IS NOTED ON THE RIGHT SIDE OF THE XRAY BUT LEFT SIDE OF THE PATIENT.

    Additional Manufacturer Narrative · 1

    VISUAL REVIEW CONFIRMS ROD BROKEN. MULTIPLE ROD BENDER POINTS AND SET SCREW WITNESS MARKS NOTED ALONG THE LENGTH OF BOTH RODS. WITNESS MARKS NOTED ADJACENT TO THE FRACTURE SURFACE. EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED MULTIMODAL FRACTURES, WITH INITIAL REGION WITH EVIDENCE OF PROGRESSIVE CONVEX STRIATIONS OR BEACH MARKS APPROXIMATELY 50% 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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT T9-ILIAC TO TREAT SCOLIOSIS. IT WAS REPORTED THAT THE RODS WERE FOUND TO BE BROKEN BILATERALLY AT L5-S1 26 MONTHS POST-OP. THE PATIENT EXPERIENCED LOWER BACK PAIN AS A RESULT. THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE BROKEN RODS AND ADD A VB REPLACEMENT AT L5/S1. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283627 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0175981W

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention SCREWS, CONNECTORS, CROSSLINKS