BEUDAMED
    FDA Adverse Event Death Summary report: N

    CALIBER

    MDR report key: 18826501 · Received March 4, 2024

    Report

    Report Number
    3004142400-2018-00047
    Event Type
    Death
    Date Received
    March 4, 2024
    Date of Event
    September 21, 2018
    Report Date
    March 4, 2024
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MAX
    UDI-DI
    00849044020298
    PMA / PMN Number
    K102293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RESUBMITTED FOR AN INCIDENT THAT OCCURRED EARLIER. HE IMPLANT AND INSTRUMENTS WERE NOT RETURNED FOR EVALUATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4, E1, E3, H2, H6, H10

    Description of Event or Problem · 0

    A REVISION SURGERY WAS PERFORMED TO REMOVE IMPLANTS AT L5-S1 AND EXTEND THE CONSTRUCT TO L4-L5 WITH BILATERAL CALIBER SPACERS AT L4-5. IT WAS DETERMINED THROUGH FINAL INTRAOPERATIVE X-RAY THAT THE CALIBER SPACER IMPLANTED ON THE PATIENT'S RIGHT WAS POSITIONED TOO FAR ANTERIOR. ATTEMPTS WERE MADE TO REMOVE AND PULL BACK THE IMPLANT; HOWEVER, THIS CAUSED THE SPACER TO ADVANCE FURTHER ANTERIORLY. THE PATIENT EXPERIENCED SIGNIFICANT BLOOD LOSS AND WAS FLIPPED SUPINE AND RECEIVED VASCULAR INTERVENTION. THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661174 CALIBER CALIBER SPACER 10 X 26MM, 9-13MM MAX GLOBUS MEDICAL, INC. 194.426 00849044020298

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Death