BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGER SPINE SYSTEM

    MDR report key: 3085192 · Received April 3, 2013

    Report

    Report Number
    1935627-2013-00005
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    April 17, 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. CORELINK WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT'S INITIAL SURGERY WAS ON (B)(6) 2011 FOR A WORKUP THAT REVEALED A GRADE I L5-S1 SPONDYLOLISTHESIS WITH A BILATERAL L5 SPONDYLOLYSIS. POST-OPERATIVE EVALUATION ON (B)(6) 2011 DID NOT REVEAL ANY CONCERNS IN THE X-RAY. POST-OPERATIVE EVALUATION ON (B)(6) 2012 ALLEGEDLY REVEALS A FRACTURE IN THE RIGHT S1 SCREW. MRI/CT CONFIRMS. PT AND PHYSICIAN DISCUSS A REVISION AND EXPLORATION OF S1 ROOT ON LEFT. THIS SECOND SURGERY TAKES PLACE ON (B)(6) 2012 FOR THE REVISION OF HER L5-S1 FUSION. RIGHT S1 SCREW IS CONFIRMED TO BE FRACTURED AND IS REPLACED WITH A 1MM LARGER DIAMETER SCREW. *7.5MM X 40MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137581 TIGER SPINE SYSTEM PEDICULE SCREW SYSTEM MNH CORELINK, LLC 55065-40 SM42966

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR