BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 3031909 · Received April 3, 2013

    Report

    Report Number
    1030489-2013-00923
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE IS NO DAMAGE NOTED TO MAS HEAD THREADED INTERFACE. VISUALLY CONFIRMED APPROXIMATELY ~3MM OF THE INSTRUMENT TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. DIMENSIONAL INSPECTION OF THE RELEVANT DIMENSION CONFIRMED CONFORMANCE TO PRINT SPECIFICATION. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD, WITH THE TIP JUST BELOW THE FRACTURE SURFACES PLASTICALLY DEFORMED. ADDITIONALLY, THE ASSEMBLY ATTACHMENT PIN TO THE INTERNAL BUSHING HAS BEEN BROKEN, CONSISTENT WITH TORSIONAL OVERLOAD CONDITION. THE ABOVE FINDINGS ARE CONSISTENT WITH TORSIONAL OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION. IT WAS REPORTED THAT WHILE TRYING TO BACK OUT A SCREW, THE SCREWDRIVER TIP BROKE AND REMAINED LODGED IN THE HEAD OF THE SCREW. THE SCREW WAS REMOVED AND REPLACED WITH ANOTHER SCREW. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136111 CD HORIZON® SPINAL SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC NA RS10M015

    Patients

    Seq Age Sex Outcome Treatment
    1