BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN GAMMA 3 LAG SCREW

    MDR report key: 18460366 · Received January 5, 2024

    Report

    Report Number
    0009610622-2024-00013
    Event Type
    Death
    Date Received
    January 5, 2024
    Date of Event
    December 7, 2023
    Report Date
    January 5, 2024
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 0

    AS DESCRIBED BY REP BELOW: "I ATTENDED A SURGERY ON (B)(6) 2023. IT WAS A REVISION GAMMA NAIL FOR A 13X440 GAMMA IN AN ELDERLY MALE PATIENT. THE LAG SCREW MISSED THE NAIL AND CONSEQUENTLY A REVISION SURGERY WAS NEEDED. FOLLOWING SURGERY THE STAFF AND SURGEON INFORMED ME THE PATIENT WAS NOT DOING WELL AND MAY NOT MAKE IT. IT WAS SUGGESTED THAT ALL GAMMA NAIL SETS ON SITE WERE CHECKED WHICH WILL HAPPEN OVER THE COURSE OF A FEW WEEKS AND I AM IN CLOSE CONTACT WITH STAFF ON SITE TO ENSURE THIS IS COMPLETED. " UPDATE 14 DEC 2023; IT HAS BEEN CONFIRMED THAT THE PATIENT HAS DIED AFTER THE REVISION SURGERY WAS PERFORMED. THIS RECORD CAPTURES THE REVISION SURGERY AND THE FOLLOWING OUTCOME OF THE PATIENT (DEATH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637930 UNKNOWN GAMMA 3 LAG SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death