BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2024190 · Received March 18, 2011

    Report

    Report Number
    1030489-2011-00307
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 15, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    KWP
    PMA / PMN Number
    K063417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    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. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    VISUALLY CONFIRMED EXTENDER STRAP BROKEN ON BOTH SIDES. UNABLE TO EXAMINE FRACTURE SURFACE, OPTICAL EXAMINATION OF BROKEN STRAP IDENTIFIED SIGNIFICANT WITNESS MARKS CLOSE TO BOTH STRAP FRACTURE LOCATIONS. IN COMPARISON WITH A SAMPLE EXTENDER, STRAP WITNESS MARKS ARE MUCH MORE PRONOUNCED THAN ON THE SAMPLE EXTENDER. THIS SUGGESTS SIGNIFICANT LOAD WAS PLACED ON THE STRAP PRIOR TO FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERCUTANEOUS LUMBAR FUSION AT L4-S1. IT WAS REPORTED THAT THE EXTENDER SLIPPED OFF OF THE SCREW BILATERALLY. THE PERCUTANEOUS TECHNIQUE WAS ABANDONED AND CONVERTED TO A MINI-OPEN TO COMPLETE THE CONSTRUCT. 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 MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA SA08C155

    Patients

    Seq Age Sex Outcome Treatment
    1 Other