BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGER SPINE SYSTEM

    MDR report key: 3037915 · Received March 5, 2013

    Report

    Report Number
    1935627-2013-00002
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 26, 2013
    Manufacturer
    CORELINK, LLC.
    Product Code
    MNH
    PMA / PMN Number
    K110321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SALES REP REC'D NOTIFICATION FROM PHYSICIAN THAT DURING POST OPERATIVE EVAL THE PT APPEARED TO HAVE EXPERIENCED BREAKAGE OF A SCREW. NO MFR PART NUMBER OR LOT NUMBER WERE ABLE TO BE OBTAINED. THEREFORE, A COMPLETE REVIEW OF THE PRODUCT WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED DURING POST-OPERATIVE EXAM THAT PEDICLE SCREW IMPLANTED DURING SURGERY ON (B)(6) 2012 APPEARED TO BE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94772 TIGER SPINE SYSTEM PEDICLE SCREW SYSTEM MNH CORELINK, LLC. 55065-45

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other