BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    INSERTER TRITANIUM TL

    MDR report key: 15691152 · Received October 28, 2022

    Report

    Report Number
    0009617544-2022-00096
    Event Type
    Malfunction
    Date Received
    October 28, 2022
    Date of Event
    October 1, 2022
    Report Date
    January 19, 2023
    Manufacturer
    STRYKER SPINE-US
    Product Code
    LXH
    UDI-DI
    07613327370096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LOT 183441. (1): MANUFACTURE DATE: 19 FEBRUARY 2019. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF Q3 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE TRITANIUM TL INSERTER JAMMING. THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF Q3 2022 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES ONE INSTANCE OF INTRAOPERATIVE TRITANIUM TL INSERTER JAMMING. THE ASSOCIATED PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2835447 INSERTER TRITANIUM TL ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER SPINE-US 48930000 183441 07613327370096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown