BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGER SPINE SYSTEM

    MDR report key: 3085191 · Received April 3, 2013

    Report

    Report Number
    1935627-2013-00006
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    August 14, 2012
    Report Date
    March 22, 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 MFR LOT NUMBER WAS ABLE TO BE OBTAINED. THEREFORE, A COMPLETE REVIEW OF THE PRODUCT WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    PT UNDERGOES L5-S1 REVISIONAL SURGERY ON (B)(6) 2012. THE RIGHT S1 SCREW WAS REPLACED WITH A 7.5MM X 40MM SCREW. A POST-OPERATIVE EXAM ON (B)(6) 2012 SHOWS THE SCREW SYSTEM TO BE INTACT. FOLLOW-UP EVAL ON (B)(6) 2012 REVEALS IN X-RAYS THE S1 SCREW ON THE RIGHT TO BE FRACTURED. ANOTHER FOLLOW-UP EVAL ON (B)(6) 2012 CONFIRMS THE SCREW FRACTURE AND ALSO SHOWS AN EVOLVING FUSION MASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137757 TIGER SPINE SYSTEM PEDICAL SCREW SYSTEM MNH CORELINK, LLC 55075-40

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other