BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER - SPLIT HEXALOBE

    MDR report key: 1880880 · Received October 4, 2010

    Report

    Report Number
    1530901-2010-00110
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 4, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SCREWDRIVER TIP BROKE OFF LEAVING THE SHEERED TIP REMAINING IN THE HEAD OF THE SCREW DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE, USING THE MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM. IT WAS STATED THAT THE PT HAD DENSE BONE. THE SCREW WAS REMOVED BY DRILLING IT OUT. THERE WAS NO ADVERSE OUTCOME FOR THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER - SPLIT HEXALOBE MANTARAY HXX THEKEN SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1