BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUOIA AND PATHFINDER NXT CLOSURE TOP

    MDR report key: 3671983 · Received February 12, 2014

    Report

    Report Number
    2184052-2014-00016
    Event Type
    Injury
    Date Received
    February 12, 2014
    Report Date
    January 20, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 60S. WEIGHT: LARGE BUILD. ADD'L RELEVANT INFO WILL BE PROVIDED WHEN THE DEVICE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    SAME PATIENT AS MDR ID: 2184052-2014-00014, 2184052-2014-00015. IT WAS REPORTED THAT POST-OPERATIVE CLOSURE TOP LOOSENING OCCURRED. AT THE TIME OF THE INDEX SURGERY, THE PATIENT UNDERWENT SURGICAL TREATMENT USING SEQUOIA INSTRUMENTATION ALONG WITH PEEK INTERBODY AND BIOLOGIC AT L4-L5 DUE TO GRADE 1 SPONDYLOLISTHESIS. ON AN UNSPECIFIED DAY FOLLOWING SURGERY, THE PATIENT HEARD SOMETHING IN HER BACK WHILE BENDING OVER. FILMS REVEALED A CLOSURE TOP AT THE L4 LEVEL HAD COME OUT OF THE SCREW HEAD. ON THE OPPOSITE SIDE, THE ROD HAD COME OUT OF THE L5 SCREW. THE CLOSURE STOP WAS STILL IN CONTACT WITH THE SCREW HEAD AT THIS LEVEL. PATIENT WAS NOT YET FUSED. REVISION SURGERY TOOK PLACE ON (B)(6) 2014. THE SURGEON REPLACED ONLY THE RODS AND CLOSURE TOPS. THE ORIGINAL SCREWS WERE LEFT IN PLACE. FILMS LATER REVEALED THE LEFT L5 SCREW HEAD HAD DISASSOCIATED FROM THE SHAFT. THE PATIENT UNDERWENT REVISION SURGERY 18 DAYS POST-OPERATIVELY. THE ENTIRE CONSTRUCT WAS REMOVED AND REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91534 SEQUOIA AND PATHFINDER NXT CLOSURE TOP SEQUOIA AND PATHFINDER NXT CLOSURE TOP NKB ZIMMER SPINE, INC. 3301-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R