BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 3063603 · Received April 17, 2013

    Report

    Report Number
    1030489-2013-01084
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO DAMAGE NOTED TO THE THREADS OF MAS HEAD THREADED INTERFACE. VISUALLY CONFIRMED APPROXIMATELY ~4MM OF THE INSTRUMENT TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. DIMENSIONAL INSPECTION OF THE INNER SHAFT DIAMETER CONFIRMED CONFORMANCE TO PRINT SPECIFICATION. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD, 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 UNSPECIFIED SPINAL PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165066 CD HORIZON® SPINAL SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC NA RS12G023

    Patients

    Seq Age Sex Outcome Treatment
    1