BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    SHORELINE ACS

    MDR report key: 14986194 · Received July 12, 2022

    Report

    Report Number
    14986194
    Event Type
    No answer provided
    Date Received
    July 12, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 22, 2022
    Manufacturer
    SEASPINE ORTHOPEDICS CORPORATION
    Product Code
    HXX
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING SURGERY WHILE SCREWING IN A SEASPINE 3.5X16MM SELF-DRILLING VARIABLE SCREW (REF (B)(4), THE ANGLED DTS SCREW DRIVER (REF: (B)(4) FROM SEASPINE BROKE AT THE ANGLED JOINT WHILE THE SURGEON WAS TRYING TO SCREW IN THE THE 3.5X16MM SCREW INTO THE PROFILE SPACER INTO BONE. CLINICAL STAFF REMOVED THE SCREW DRIVER. THE SURGEON WAS ABLE TO SET THE SCREW INTO THE PROFILE SPACER WITH ANOTHER SCREW DRIVER FROM THE SEASPINE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700420 SHORELINE ACS SCREWDRIVER HXX SEASPINE ORTHOPEDICS CORPORATION 86-1130

    Patients

    Seq Age Sex Outcome Treatment
    1 14965 DA Unknown