BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILE TALOS-TL (HA) PEEK IBFD

    MDR report key: 12696999 · Received October 25, 2021

    Report

    Report Number
    MW5104931
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    October 12, 2021
    Report Date
    October 21, 2021
    Manufacturer
    MEDITECH SPINE, LLC.
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROVIDER DILATED L5-S1 VERTEBRAL SPACE USING TWO INTERBODY INFUSION GRAFTS, (TALOS-TL (HA) PEEK IBFD MANUFACTURED BY MEDITECH SPINE, LLC). THE FIRST GRAFT WAS INSERTED WITHOUT ISSUE. AS THE PROVIDER WAS INSERTING THE SECOND GRAFT, IT BROKE INTO SEVERAL FRAGMENTS TEARING THE THECAL SAC CAUSING A DURAL TEAR WHICH THEN REQUIRED SURGICAL REPAIR BY THE PROVIDER. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS, RECOVERED WELL AND HAD NO FURTHER COMPLICATIONS. FDA SAFETY REPORT ID# (B)(4). .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592266 STERILE TALOS-TL (HA) PEEK IBFD INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDITECH SPINE, LLC. NA 3772-23-1

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization