BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2112406 · Received June 3, 2011

    Report

    Report Number
    1030489-2011-00660
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 31, 2011
    Report Date
    July 14, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SCREW 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

    MACROSCOPIC EXAMINATION CONFIRMS MAS BROKEN APPROX. ~3 THREADS BELOW SCREW HEAD. DAMAGED NOTED ON MAS HEAD PORTION OF IMPLANT, WITH SEVERE DAMAGE NOTED ON BONE SCREW PORTION OF BROKEN IMPLANT. MICROSCOPIC EXAMINATION OF FRACTURE SURFACE REVEALS A FAIRLY FLAT FRACTURE SURFACE, WITH PROGRESSIVE STRIATIONS, INDICATIVE OF FATIGUE, FOLLOWED BY ULTIMATE FAILURE OF THE IMPLANT, CONSISTENT WITH FAILURE DUE TO FATIGUE.

    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. SEE ALSO MFR REPORT # 1030489-2011-00368.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY AND THE BROKEN SCREW WAS REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR SPINAL SURGICAL PROCEDURE AT L4-S1. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AFTER FALLING DOWN IN THE DRIVEWAY APPROXIMATELY 2 MONTHS POST-OP TO REPLACE A BROKEN SCREW AT S1. APPROXIMATELY 3 MONTHS AFTER THE REVISION SURGERY THE PATIENT BROKE THE SCREW WAS IMPLANTED DURING THE REVISION. NO REVISION HAS BEEN SCHEDULED YET. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN 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 H10D0138

    Patients

    Seq Age Sex Outcome Treatment
    1 00005 YR Required Intervention ROD, SCREWS