BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICAID ACD

    MDR report key: 17541964 · Received August 14, 2023

    Report

    Report Number
    3006232063-2023-00025
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 24, 2023
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA810MM0
    PMA / PMN Number
    P160050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGEON AND PROCTOR NARRATIVE DOES NOT SUGGEST THAT THERE WERE ANY TECHNIQUE RELATED ISSUES WITH THE USE OF THE DEVICE. A LOT HISTORY REVIEW WAS PERFORMED, AND NOTHING ALLUDED TO A CONCLUSION TO WHY THIS OCCURRED. THE DEVICE WAS DISCARDED AND NOT RETURNED FOR REVIEW, SO THERE WAS NO DETAILED ANALYSIS OF THE THE DEVICE THAT FRACTURED.

    Description of Event or Problem · 0

    PER SURGICLOUD NOTES: "NITINOL WIRE SNAPPED AT BASE OF IMPLANT TOOL. DR. (B)(6) BELIEVE(SIC) THE SNAPPED WIRE HIT DURA AND CAUSED DURAL TEAR WHICH HAD TO BE REPAIRED WITH DURA SEAL AND SUTURE DUE TO TEAR" THE REMOVAL TOOL WAS USED TO REMOVE THE PARTIALLY IMPLANTED ANCHOR FROM THE VERTEBRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310894 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-10MM 04302120 M906BARA810MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O