BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1820032 · Received August 20, 2010

    Report

    Report Number
    1030489-2010-01078
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    PMA / PMN Number
    K051674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVAL, 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 SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A MINIMALLY INVASIVE POSTERIOR SPINAL SURGERY. IT WAS REPORTED THAT THE ROD INSERTER TAB BROKE, ALLOWING THE TROCAR TO DISLODGE EASILY. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ROD INSERTER NKB MEDTRONIC SOFAMOR DANEK NA M06B0034-B

    Patients

    Seq Age Sex Outcome Treatment
    1 TROCAR| EXPLANT:| IMPLANT: