BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL SCREW INSERTER

    MDR report key: 1834497 · Received September 10, 2010

    Report

    Report Number
    1530901-2010-00075
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 10, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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

    IT WAS REPORTED THAT DURING A SPINAL SURGERY PROCEDURE INVOLVING THE CORAL SPINAL FUSION IMPLANT SYSTEM, INDICATED FOR THE CORRECTION AND STABILIZATION OF THE LUMBAR OR LOWER REGION, THE SCREW INSERTED FAILED TO HOLD THREE SCREWS IN A LINEAR ALIGNMENT ON THE SCREW INSERTER. THEY COULD NOT BE USED, AND THEY WERE RELEASED FROM THE SCREW INSERTER IN AN AREA OUTSIDE OF THE PT'S SURGICAL WOUND. SURGERY TIME WAS EXTENDED BY ABOUT FIVE TO 10 MINUTES BECAUSE THE SURGEON HAD DIFFICULTY LOADING THE SCREWS ONTO THE INSERTER. THE DAY FOLLOWING THE SURGERY THE SCREW INSERTER TIP WAS FOUND TO BE MISSING. MANY X-RAYS OF THE PT HAD BEEN TAKEN DURING THE CASE WHILE IMPLANTING THE LAST SCREW, DURING INSERTION OF THE CAGE, AND WHEN THE PROCEDURE WAS COMPLETED, AND AT NO TIME WAS THE SCREWDRIVER TIP OBSERVED IN THE PT. AT THE COMPLETION OF THE SURGERY, ALL PRODUCTS THAT HAD BEEN IMPLANTED WERE CONSIDERED TO HAVE PERFORMED AS USUAL, AND THERE WERE NO CONCERNS ABOUT THEIR INTEGRITY INSIDE THE PT.

    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