BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIRBOLOX TLIF LUMBAR IBFD

    MDR report key: 12865257 · Received November 23, 2021

    Report

    Report Number
    3006082533-2021-00001
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    September 6, 2021
    Report Date
    November 18, 2021
    Manufacturer
    CAPTIVA SPINE
    Product Code
    MAX
    UDI-DI
    M739PI01000
    PMA / PMN Number
    K180990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR REPORT IS PAST THE REPORTING DATE DUE TO GAINING ACCESS TO ESG PROTAL FOR REPORTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS MDR REPORT IS PAST THE REPORTING DATE DUE TO GAINING ACCESS TO ESG PROTAL FOR REPORTING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 0

    A FIELD FEEDBACK REPORT WAS REPORTED TO THE COMPANY THAT THERE WAS AN INCIDENT DURING A LUMBAR TLIF PROCEDURE USING THE PIVOTEC INSERTER AND LUMBAR INTERBODY IMPLANT, THAT MAY HAVE CONTRIBUTED TO A DURAL TEAR. DURING INSERTION OF THE IMPLANT IT WAS DESCRIBED THAT THE IMPLANT/INSTRUMENT INTERFACE HAD UNINTENTIONAL MOVEMENT FROM THE FULLY LOCKED POSITION DURING IMPACTION AND INSERTION. THERE WAS LESS THAN 20 MINUTES SURGICAL DELAY REQUIRED TO ADDRESS THE DURAL TEAR. NO ADDITIONAL CLINICAL INFORMATION WAS PROVIDED, AND NO FURTHER HEALTH DAMAGE REPORTED IN THE PATIENT.

    Description of Event or Problem · 0

    A FIELD FEEDBACK REPORT WAS REPORTED TO THE COMPANY THAT THERE WAS AN INCIDENT DURING A LUMBAR TLIF PROCEDURE USING THE PIVOTEC INSERTER AND LUMBAR INTERBODY IMPLANT, THAT MAY HAVE CONTRIBUTED TO A DURAL TEAR. DURING INSERTION OF THE IMPLANT IT WAS DESCRIBED THAT THE IMPLANT/INSTRUMENT INTERFACE HAD UNINTENTIONAL MOVEMENT FROM THE FULLY LOCKED POSITION DURING IMPACTION AND INSERTION. THERE WAS LESS THAN 20 MINUTES SURGICAL DELAY REQUIRED TO ADDRESS THE DURAL TEAR. NO ADDITIONAL CLINCAL INFORMATION WAS PROVIDED, AND NO FURTHER HEALTH DAMAGE REPORTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761667 TIRBOLOX TLIF LUMBAR IBFD LUMBAR INTERBODY FUSION DEVICE MAX CAPTIVA SPINE PI-0100 09160005 M739PI01000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other TLIF TITANIUM CAGE PIV-CVD PARALLEL 30MM X 12MM.