BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICAID ACD

    MDR report key: 17391963 · Received July 25, 2023

    Report

    Report Number
    3006232063-2023-00022
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    May 29, 2023
    Report Date
    July 25, 2023
    Manufacturer
    INTRINSIC THERAPEUTICS, INC
    Product Code
    QES
    UDI-DI
    M906BARA88MM0
    PMA / PMN Number
    P160050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTRINSIC THERAPEUTICS BECAME AWARE OF BOTH SURGICAL INTERVENTIONS AT THE SAME TIME DURING THE REMOVAL SURGERY WHERE WE HAD A PROCTOR PRESENT. AFTER INVESTIGATING THIS ISSUE, OFF LABEL USAGE HAS BEEN IDENTIFIED AS THE PRIMARY CAUSE OF THE POST OPERATIVE COMPLICATIONS. THE DEVICES ARE INDICATED FOR "...FOLLOWING A PRIMARY DISCECTOMY PROCEDURE...". THIS WAS NOT THE PRIMARY DISCECTOMY AT THIS INDEX LEVEL. IMPROPER USAGE OF THE DEVICE ON INITIAL IMPLANTATION WAS IDENTIFIED AS THE PRIMARY REASON FOR THE RESIDUAL HERNIATION. THE INFECTION THAT WAS NOTED IS A HAZARD OF ANY SURGERY AND NO OTHER INFECTIONS HAVE BEEN REPORTED FOR THIS LOT OF DEVICES. THE SURGEON LEAVING THE DEVICE IMPLANTED AND NO OTHER INCIDENTS WITHIN THIS LOT LEADS TO THE CONCLUSION OUR DEVICE WAS NOT RESPONSIBLE FOR THIS INFECTION.

    Description of Event or Problem · 0

    DURING A BARRICAID IMPLANT REMOVAL ON (B)(6) 2023, THE FOLLOWING WAS NOTED: A. THE SURGEON PERFORMING THE REMOVAL SURGERY VERBALLY STATED TO THE PROCTOR THAT THERE WAS A REVISION SURGERY DATED (B)(6) 2023 TO THE INITIAL IMPLANTATION WHERE A RESIDUAL HERNIATION WHICH WAS ADDRESSED, AN INFECTION OF SERRATIA WAS TREATED, AND A LEAK OF CRANIAL SPINAL FLUID WAS REPAIRED. B. AFTER THE PATIENT EXPERIENCED A COMPLETE DISC COLLAPSE THE REMOVAL WAS SCHEDULED FOR (B)(6) 2023 TO MAKE ROOM FOR AN ALIF, IT WAS ALSO NOTED THAT THE PATIENT HAD DEVELOPED INSTABILITY DUE TO PARS DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635194 BARRICAID ACD BARRICAID QES INTRINSIC THERAPEUTICS, INC BAR-A8-8MM 02272301 M906BARA88MM0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other