BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL SCREW INSERTER

    MDR report key: 1881743 · Received October 11, 2010

    Report

    Report Number
    1530901-2010-00125
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 11, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A SPINAL SURGERY PROCEDURE, THE CORAL SCREWDRIVER TIP BROKE OFF IN THE SCREW, WHICH WAS BEING INSERTED AT AN EXTREME ANGLE. THE SCREW HAD TO BE REMOVED. THE COLLET OF THE SCREW WAS SNAPPED OFF FROM THE SCREW; THE UNIVERSAL SYSTEM WAS USED TO REMOVE THE SCREW. THE SURGERY WAS PROLONGED BY ABOUT TWENTY MINUTES. THE CORAL SPINAL SYSTEM IS A FUSION IMPLANT SYSTEM USED FOR THE CORRECTION AND STABILIZATION OF THE LUMBAR OR LOWER REGION OF THE SPINE. THERE WERE NO ADVERSE OUTCOMES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR