BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVICAL IMPLANT 16X14X7MM

    MDR report key: 2566119 · Received May 3, 2012

    Report

    Report Number
    3008657535-2012-00039
    Event Type
    Malfunction
    Date Received
    May 3, 2012
    Date of Event
    April 26, 2012
    Report Date
    May 3, 2012
    Manufacturer
    THEKEN SPINE LLC
    Product Code
    ODP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A SPINAL SURGERY PROCEDURE, THE SURGEON WAS UNABLE TO OBTAIN THE CORRECT ANGLE FOR ONE OF THE SCREWS AND IT STRIPPED OUT THE COMPLETE CERVICAL CAGE. THE CAGE AND BOTH SCREWS THAT HAD BEEN PLACED HAD TO BE REMOVE, AND THE PROCEDURE WAS COMPLETED USING A CERVICAL PLATE INSTEAD. SCREWS THAT WERE USED WITH THE CAGE WERE PART NUMBER 27-14-3514 (3.5X 14MM) AND PART NUMBER 27-14-3516 (3.5X16MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERVICAL IMPLANT 16X14X7MM COMPLETE ODP THEKEN SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1