BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 3032068 · Received April 3, 2013

    Report

    Report Number
    1030489-2013-00926
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT APPROXIMATELY ~3MM OF THE INSTRUMENT TIPS HAVE BEEN BROKEN OFF AND NOT RETURNED FOR ANALYSIS; THIS IS CONSISTENT WITH SET SCREW INTERFACE DURING USAGE. FRACTURE SURFACE DAMAGE NOTED. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT DUCTILE FRACTURE WITH CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD, WITH PLASTIC DEFORMATION OF REMAINING PORTION OF THE TIP, JUST BELOW THE FRACTURE. DIMENSIONAL INSPECTION OF THE TIP DIAMETER CONFIRMS CONFORMANCE TO PRINT SPECIFICATION. THE ABOVE FINDINGS ARE CONSISTENT WITH TORSIONAL OVERLOAD.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION AT L4-L5 TO TREAT LSCS. IT WAS REPORTED THAT DURING FINAL TIGHTENING, THE TIP OF THE DRIVER FRACTURED, AND THE FRAGMENT REMAINED IN THE SETSCREW HEAD. THE SURGEON TRIED TO REMOVE THE FRAGMENT BUT FAILED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136531 CD HORIZON® SPINAL SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA GB12C008

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR