BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, UNKNOWN

    MDR report key: 1881961 · Received October 12, 2010

    Report

    Report Number
    1530901-2010-00127
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    July 31, 2010
    Report Date
    October 12, 2010
    Manufacturer
    THEKEN SPINE
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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 THE MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM WAS IMPLANTED IN ABOUT (B)(6) 2009, OR (B)(6) 2010 FOR RADICULOPATHY. THE PT WAS A TOBACCO SMOKER WHO CONTINUED TO SMOKE POSTOPERATIVELY AGAINST MEDICAL ADVICE. AT A FOLLOW UP OFFICE VISIT, BONE GRAFT SUBSIDENCE WAS OBSERVED ON RADIOGRAPHS, AND A LOWER LEVEL SCREW WAS SEEN TO HAVE BACKED OUT FROM THE PLATE. THE PT DID NOT RETURN FOR AN ADVISED CLINICAL FOLLOW UP VISIT. INTEGRA HAS REQUESTED, IN WRITING, ADDITIONAL CLINICAL INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1