BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGER

    MDR report key: 4961336 · Received July 30, 2015

    Report

    Report Number
    1935627-2015-00002
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    February 28, 2014
    Report Date
    July 29, 2015
    Manufacturer
    CORELINK, LLC
    Product Code
    MCV
    PMA / PMN Number
    K110321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION COULD BE OBTAINED ON THE USE OR THE SCENARIO IN HOW THIS OCCURRED.

    Description of Event or Problem · 1

    DURING A SURGERY ON (B)(6) 2014 THE SURGEON PERFORMED A REVISION SURGERY FOR A SCREW THAT FRACTURED WITHIN THE BODY CAVITY. THE LEVEL ABOVE THE SCREW HAD DEGENERATED. THE FRACTURED SCREW WAS REMOVED AND THE SURGEON RE-INSTRUMENTED THE DISC SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498263 TIGER PEDICLE SCREW MCV CORELINK, LLC 5500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention