BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGER SPINE SYSTEM

    MDR report key: 3060927 · Received April 10, 2013

    Report

    Report Number
    1935627-2013-00013
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 20, 2013
    Report Date
    April 5, 2013
    Manufacturer
    CORELINK, LLC
    Product Code
    MNH
    PMA / PMN Number
    K110321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    TIGER SPINE SYSTEM PEDICLE SCREWS WERE IMPLANTED ON (B)(6) 2013. DURING A POST-OPERATIVE EVALUATION ON (B)(6) 2013 THE PHYSICIAN DETERMINED THAT THE RIGHT S1 PEDICLE SCREW FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153718 TIGER SPINE SYSTEM PEDICLE SCREW SYSTEM MNH CORELINK, LLC 55065-40

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR