BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH

    MDR report key: 4933276 · Received July 22, 2015

    Report

    Report Number
    1030489-2015-01578
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    June 23, 2015
    Report Date
    August 26, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS :VISUAL REVIEW CONFIRMS ROD BREAKAGE. MULTIPLE ROD BENDER POINTS AND SET SCREW WITNESS MARKS NOTED, ALONG THE LENGTH OF BOTH RODS, INCLUDING IMMEDIATE PROXIMITY TO THE FRACTURE SURFACES. LIGHT SURFACE WITNESS MARKS IDENTIFIED, BUT NO SURFACE DEFECT THAT COULD PROMOTE CRACK INITIATION AND PROPAGATION IDENTIFIED. FRACTURE SURFACE DAMAGE AND SMEARING NOTED. EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED MULTIMODAL FRACTURES, WITH SMALL INITIAL REGION OF SUB-CRITICAL OVERLOAD, WITH THE REMAINING CROSS-SECTIONAL AREA DISPLAYING EVIDENCE OF PROGRESSIVE CONVEX STRIATIONS OR BEACH MARKS, UNTIL 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.

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 828-090, 510K # K964275 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR SPINAL FUSION WITH PSO AT TH10-IL LEVELS FOR TREATING KYPHOSIS. POST-OP, ROD BREAKAGE WAS FOUND. REVISION SURGERY WAS SCHEDULED TO REPLACE BROKEN ROD WITH THREE RODS CONSTRUCT AND ADD PLIF AT 5/S LEVEL ON (B)(6) 2015. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN. THE REVISION SURGERY WAS OPERATED TO ADD PLIF AT L2/3, L4/5 LEVELS AND REPLACE BROKEN ROD (THREE RODS CONSTRUCT AT L1-S1). NO FURTHER PROBLEM WAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475627 TSRH APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0268957W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention