BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 2303483 · Received October 21, 2011

    Report

    Report Number
    1030489-2011-01354
    Event Type
    Injury
    Date Received
    October 21, 2011
    Report Date
    September 21, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    PMA / PMN Number
    K091974
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATION. MEDTRONIC, INC.

    Additional Manufacturer Narrative · 1

    THE SCREWS WERE RETURNED FOR EVALUATION. VISUALLY CONFIRMED BOTH MAS SCREWS BROKEN AT THE BASE OF THE BONE SCREW HEAD. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACES APPEAR TO DISPLAY EVIDENCE OF MULTI-MODAL FRACTURES. THE INITIATION AREA IS A FAIRLY FLAT FRACTURE SURFACE WITH PROGRESSIVE STRIATIONS WHICH ARE INDICATIVE OF FATIGUE, FOLLOWED BY A QUASI-BRITTLE FRACTURE SURFACE, WITH RIVER LINES AND SHEAR LIPS, SUGGESTING THE ULTIMATE FAILURE MODE AS SINGLE CYCLE BEND STRESS OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT L5-S1. IT WAS REPORTED THAT SOMETIME POST-OP THE PATIENT HAD TWO SCREWS SHEAR AT S1. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE HARDWARE AND REPLACE WITH NEW HARDWARE AND EXTEND THE CONSTRUCT TO L4-S1. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON® SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H10J0326

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention