BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCORDER PROTI 5 DG 9X 8 X23 MM

    MDR report key: 14846837 · Received June 28, 2022

    Report

    Report Number
    3012966183-2022-00024
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 28, 2022
    Manufacturer
    TYBER MEDICAL
    Product Code
    MAX
    UDI-DI
    00819917020922
    PMA / PMN Number
    K172185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE HISTORY RECORD REVIEW PERFORMED AS THERE WAS NO LOT INFORMATION FORTHCOMING FROM THE COMPLAINANT. THE REPORT SHOWS THAT 2 LITERS OF BLOOD WERE LOST PRIOR TO CAGE INSERTION. AS CONFIRMED BY ORTHOPEDIC SURGEON CONSULTATION THIS DOES NOT INDICATE A DEVICE ISSUE BUT RATHER VASCULAR DAMAGE DURING EXPOSURE AND/OR DISC PREPARATION. THE ADDITIONAL LOSS OF 3.5L OF BLOOD DURING CAGE INSERTION INDICATES THE VASCULAR DAMAGE WAS NOT ADDRESSED FOLLOWING DISC PREPARATION. THE INVESTIGATION INDICATES THE SURGEON SEVERELY DAMAGED VASCULAR ANATOMY DURING EXPOSURE AND/OR DISC PREPARATION AND FAILED TO APPROPRIATELY ADDRESS THE DAMAGE PRIOR TO CAGE INSERTION. THIS IS SUPPORTED BY THE 2L OF BLOOD LOSS RECORDED PRIOR TO CAGE INSERTION, AND 3.5L OF BLOOD LOSS RECORDED FOLLOWING CAGE INSERTION. THE ORTHOPEDIC SURGEON WAS CONSULTED ABOUT THE REPORTED EVENT AND HIS RESPONSE SUPPORTS THIS CONCLUSION. THE ROOT CAUSE IT TRACED TO USER.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE THE PATIENT UNDERWENT A PRIMARY PROCEDURE AT A DIFFERENT HOSPITAL. ON (B)(6) 2022 THE PATIENT UNDERWENT A PLIF REVISION PROCEDURE (L3/4/5). THE SURGEON TOOK THE FOLLOWING STEPS. 2,000 CC OF HEMORRHAGE WAS RECORDED DURING DECOMPRESSION. ENSUING PROCEDURES UP TO DEPLOYING A CAGE WAS PERFORMED WITHOUT AN ISSUE. AFTER THE CAGE WAS DEPLOYED, 3,500 CC OF HEMORRHAGE WAS RECORDED. WHILE THEY WERE TAKING A MEASURE TO STOP THE HEMORRHAGE, THE PATIENT WENT INTO CARDIOPULMONARY ARREST. THEY CLOSED THE INCISION AND STOPPED FURTHER SPINE PROCEDURE. THE ANESTHETIC TEAM TOOK A RESUSCITATION TREATMENT, AND AN ELECTROCARDIOGRAM SHOWED A RESUSCITATED CARDIAC STATUS. THE PROCEDURE WAS DELAYED BY MORE THAN 30 MINUTES. THE SURGEON COMMENTED THE FOLLOWING: THE PATIENT HAS BEEN SUPPORTED BY A CARDIAC PACEMAKER DUE TO IRREGULAR PULSE. THE SPINE REVISION WILL BE RESCHEDULED. IT WAS NOT CONFIRMED IF THE IMPLANTS MIGHT HAVE TRIGGERED THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042705 CONCORDER PROTI 5 DG 9X 8 X23 MM INTERBODY SPACERS MAX TYBER MEDICAL 188823408 00819917020922

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening