BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 2935723 · Received January 30, 2013

    Report

    Report Number
    1030489-2013-00295
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 7, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    PMA / PMN Number
    K091974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    VISUAL REVIEW CONFIRMS SCREW BREAKAGE AT THE BASE OF THE BONE SCREW NECK, PRIOR TO THE START OF THE THREAD. OPTICAL EXAMINATION OF ADJACENT SURFACES AROUND THE AREA OF CRACK PROPAGATION DID NOT IDENTIFY MATERIAL SURFACE DEFECT THAT COULD CONTRIBUTE TO CRACK PROPAGATION. DAMAGE AND/OR SMEARING NOTED TO ALL FRACTURE SURFACES. 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 AT APPROXIMATELY 50% OF THE WAY THROUGH THE CROSS-SECTIONAL AREA, CONSISTENT WITH OVERLOAD. DIMENSIONAL EXAMINATION CONFIRMED CONFORMANCE TO PRINT SPECIFICATION OF THE BONE SCREW DIAMETER AT THE BASE OF THE HEAD. 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

    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 A POSTERIOR LUMBAR FUSION/ TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1. APPROXIMATELY 19 MONTHS POST OP, AN X-RAY SHOWED THAT THE IMPLANTED SCREW WAS BROKEN. THE PATIENT WAS REVISED AND THE BROKEN SCREW WAS EXPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40556 CD HORIZON® SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H10H0705

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR