BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, UNK

    MDR report key: 1881937 · Received October 12, 2010

    Report

    Report Number
    1530901-2010-00128
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    December 31, 2009
    Report Date
    October 12, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PATIENT HAD A SPINAL SURGERY PROCEDURE FOR RADICULOPATHY USING A SYNTHES PLATE. THIS PLATE WAS REMOVED AND A MANTA RAY PLATE WAS PLACED IN LATE 2009. ABOUT THREE TO FOUR WEEKS AFTER THIS SURGERY, AT A ROUTINE POST OPERATIVE VISIT, IT WAS SEEN ON X-RAY IMAGING THAT ONE LOWER SCREW HAD BACKED OUT OF THE PLATE BY A FEW MILLIMETERS. THE PATIENT DID NOT RETURN TO THE SURGEON FOR FOLLOW UP VISITS. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFORMATION FROM THE REPORTER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW, UNK MANTA RAY KWQ THEKEN SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1