BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW UNKNOWN

    MDR report key: 1900526 · Received October 29, 2010

    Report

    Report Number
    1530901-2010-00132
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 26, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE 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 USING A 2 LEVEL CORAL PEDICLE SCREW SYS AT VERTEBRAL LEVELS L3-L5, THE SCREW AT L5 WAS LOCKED DOWN TO THE ROD, AND WHILE TRYING TO DO THE REDUCTION AT L4, THE L5 SEAT MOVED AND PREVENTED THE PHYSICIAN FROM DONG THE REDUCTION AT L4. HE COMPLETED THE PROCEDURE USING PLIERS TO HOLD THE SEAT AND ROD STEADY. THIS ADDED APPROX ONE HALF HOUR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW UNKNOWN CORAL KWP THEKEN SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1