BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2093955 · Received May 18, 2011

    Report

    Report Number
    1030489-2011-00557
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 15, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    KWP
    PMA / PMN Number
    K052747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 NON-CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. MACROSCOPIC EXAMINATION CONFIRMS THE LATERAL GUIDING FLANGE IS BROKEN. OPTICAL EXAMINATION OF BROKEN STRAP IDENTIFIED WITNESS MARKS. IN COMPARISON WITH A SAMPLE INSTRUMENT, STRAP WITNESS MARKS ARE LARGER AND MORE PRONOUNCED; THIS SUGGESTS SIGNIFICANT LOAD MAY HAVE BEEN PLACED ON THE STRAP PRIOR TO FAILURE, EITHER THROUGH INAPPROPRIATE SURGICAL TECHNIQUE OR AN OUT OF SPECIFICATION INNER SLEEVE. THE INNER SLEEVE WAS NOT RETURNED FOR ANALYSIS. FRACTURE SURFACE DAMAGE NOTED. LIGHT LENGTHWISE STRIATIONS ARE NOTED AND PROVIDE SOME EVIDENCE OF A FATIGUE COMPONENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERCUTANEOUS THORACIC FUSION AT T8-T12. IT WAS REPORTED THAT THE OUTER SLEEVE DISCONNECTED FROM THE BONE SCREW. UPON REMOVAL OF THE OUTER SLEEVE IT WAS NOTICED THAT THE BASE OF THE SLEEVE WAS CRACKED. ANOTHER SLEEVE WAS USED TO COMPLETE THE CASE. NO 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 MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA RS07J050

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW