BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGER

    MDR report key: 4961347 · Received July 30, 2015

    Report

    Report Number
    1935627-2015-00005
    Event Type
    Malfunction
    Date Received
    July 30, 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

    NO FURTHER INFORMATION COULD BE OBTAINED ON THE USE OF THE SCENARIO IN HOW THIS OCCURRED. THE SET SCREW AND PEDICLE SCREW WERE BOTH RETURNED AND ALL SPECIFICATION WERE FOUND TO BE WITHIN SPECIFICATIONS. THE TORQUE HANDLE WAS ALSO RETURNED AND FOUND TO MEET SPECIFICATION. DHR WAS REVIEWED AND NO IRREGULARITIES IN THE PRODUCTION PROCESS COULD BE IDENTIFIED.

    Description of Event or Problem · 1

    THE SET SCREW CAME LOOSE FROM THE SCREW CAUSING THE ROD TO COME FREE OF THE CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498486 TIGER SET SCREW MNH CORELINK, LLC 5500 SERIES SM55288

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R