BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGER

    MDR report key: 4961362 · Received July 30, 2015

    Report

    Report Number
    1935627-2015-00007
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    June 12, 2015
    Report Date
    July 29, 2015
    Manufacturer
    CORELINK, LLC
    Product Code
    MNH
    PMA / PMN Number
    K110321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DHR SHOWED NO IRREGULARITIES IN THE PRODUCTION PROCESS FOR THIS PART. PHYSICAL REVIEW OF THE SET SCREW IDENTIFIED NO IRREGULARITIES. PRODUCT WAS WITHIN SPECIFICATION. MATING TULIP HEAD REVIEWED AND ALSO FOUND WITHIN SPECIFICATION. TORQUE HANDLES THAT WERE HELD BY THE DISTRIBUTOR WERE ALSO REVIEWED AND NO DATA WAS RETRIEVED THAT WOULD LEAD TO THE TORQUE OF THE SET SCREW BEING INCORRECT. DISTRIBUTOR IDENTIFIED THAT THROUGH FURTHER DISCUSSION WITH THE SURGEON THERE IS A BELIEF THAT THE CROSS CONNECTOR WAS PLACED TO CLOSE TO THE TULIP HEAD AND MAY HAVE LEAD TO THIS MALFUNCTION.

    Description of Event or Problem · 1

    SURGERY WAS DONE IN (B)(6) 2014. SOMETIME IN THE END OF (B)(6) 2015 THE PATIENT IDENTIFIED A PAIN ON THE RIGHT SIDE OF HIS BODY AS A GENERAL COMPLAINT. THE PLAN WAS TO EXPLORE THE PREVIOUS FUSION AT L4/5 AND EXTEND TO L3. WHEN EXPOSURE TO DO THIS WAS MADE IT WAS IDENTIFIED THAT A SET SCREW HAD COME LOOSE FROM THE TULIP HEAD, AND THIS WAS NOT ABLE TO NOTICED ON THE X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498194 TIGER SET SCREW MNH CORELINK, LLC SM59033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other