BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2742520 · Received September 13, 2012

    Report

    Report Number
    1030489-2012-01595
    Event Type
    Injury
    Date Received
    September 13, 2012
    Date of Event
    August 19, 2012
    Report Date
    August 21, 2012
    Manufacturer
    SEE H10
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL REVIEW CONFIRMS MAS BREAKAGE AT APPROXIMATELY 2-3 THREADS FROM THE BONE SCREW HEAD. OPTICAL EXAMINATION OF ADJACENT SURFACES TO FRACTURE DID NOT IDENTIFY MATERIAL SURFACE DEFECT THAT COULD CONTRIBUTE TO CRACK PROPAGATION. DAMAGE TO THE LOWER BROKEN PORTION OF THE BONE SCREW IS CONSISTENT WITH EXPLANTATION. FRACTURE SURFACE EXAMINATION IDENTIFIED A MULTI-MODAL FRACTURE, WITH PROGRESSIVE STRIATIONS EMANATING AWAY FROM THE ORIGIN OF INITIAL FRACTURE PROPAGATION AS NOTED, AS WELL AS INCREASED MATERIAL DISRUPTION AND RIVER LINES CONSISTENT WITH OVERLOAD ON BOTH SIDES OF THE FRACTURE. DIMENSIONAL EXAMINATION CONFIRMED CONFORMANCE TO PRINT SPECIFICATION OF RELEVANT DIMENSIONS. AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT OR ASSOCIATED COMPONENTS; UNABLE TO DEFINITIVELY DETERMINE SPECIFIC ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    LOT W08G1062, 0022462W, 0033975W. (B)(6). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE PART# 75446540, LOT H09E6915; PART #75445550, LOT W08G1062; PART 75496545, LOT 0022462W; LOT 0033975W. (B)(4). THE MANUFACTURE DATE FOR LOT H09E6915 IS 06/05/2009; THE MANUFACTURE DATE FOR LOT W08G1062 IS 07/09/2008; THE MANUFACTURE DATE FOR LOT 0022462W IS 03/12/2009, THE MANUFACTURE DATE FOR LOT 0033975W IS 05/11/2009. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A L4, L5, S1 INTERNAL FIXATION SURGICAL PROCEDURE. APPROXIMATELY 3 YEARS POST-OP IT WAS FOUND DURING A CHECKUP THAT THE PEDICLE SCREWS AT L5 AND S1 WERE BROKEN. THE PATIENT UNDERWENT A REVISION SURGERY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP SEE H10 NA H09E6915

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention