BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENSTRATED POLY REDUCTION SCREW, 6.5 X 55 MM

    MDR report key: 2061486 · Received March 16, 2011

    Report

    Report Number
    3008657535-2011-00004
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 16, 2011
    Manufacturer
    INTEGRA, MEDINA
    Product Code
    KWQ
    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 INFORMATION.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A POSTERIOR FUSION OF LUMBAR VERTEBRAE REGION 3-4 (SPINAL SURGERY) ON A SIXTY ONE YEAR OLD MALE PATIENT. THE SURGEON WAS PLACING SCREWS IN THE AREA OF THE FUSION. SHE WAS USING THE FENESTRATED EXTENDED TAB CORAL SCREW (6.5X55MM) PART # 18-26-6555, LOT # 11482 WITH A POWER DRIVER. ALL OF THE SCREWS WERE LOADED WHILE ON THE POWER DRIVER. AFTER PLACING ALL OF THE SCREWS, SHE DID NOT LIKE THE WAY ONE WAS POSITIONED ON THE AREA OF LUMBAR VERTEBRAE # 4. THE PHYSICIAN REMOVED THAT SCREW AND RELOADED THE SAME SCREW TO INSERT. SHE RE-TAPPED ON THE INSERTION OF THE SCREW AND THE SHAFT OF THE SCREW BROKE OFF FROM THE HEAD OF THE SCREW. THE SCREW WAS PARTIALLY IN SURGICAL SITE OF THE PEDICLE OF THE VERTEBRAE WHEN THE HEAD BROKE OFF. ALL OF THE PIECES OF THE IMPLANT WERE RECOVERED. A NEW SCREW WAS LOADED ON THE DRIVER AND PLACED IN THE SITE TO COMPLETE THE SURGERY WITHOUT ANY ISSUES. SURGICAL TIME WAS NOT EXTENDED DUE TO THE INCIDENT MORE THAN FIVE MINUTES. THERE WAS NO ADVERSE EVENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FENSTRATED POLY REDUCTION SCREW, 6.5 X 55 MM CORAL KWQ INTEGRA, MEDINA W11482

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR