BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 3063244 · Received April 17, 2013

    Report

    Report Number
    1030489-2013-01076
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUALLY CONFIRMED APPROXIMATELY ~3MM OF BOTH INSTRUMENT TIPS HAVE 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 A LUMBAR FUSION. IT WAS REPORTED 'THAT THE SCREW STOPPED AT THE BONE, WHEN THE SURGEON TRIED TO ADVANCE THE SCREWDRIVER IT FELL APART. NO PATIENT COMPLICATIONS WERE REPORTED.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164061 CD HORIZON® SPINAL SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC NA RS11F003

    Patients

    Seq Age Sex Outcome Treatment
    1