BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    VLIFT INSIDE SHAFT

    MDR report key: 16837956 · Received April 28, 2023

    Report

    Report Number
    0009617544-2023-00017
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    April 1, 2023
    Report Date
    July 22, 2023
    Manufacturer
    STRYKER SPINE-US
    Product Code
    LXH
    UDI-DI
    07613327267020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LOT 208569 (1): MANUFACTURE DATE 17 DECEMBER 2020, DEVICE RETURNED 19 APRIL 2023 LOT 212228 (1): MANUFACTURE DATE 09 APRIL 2021, DEVICE RETURNED 19 APRIL 2023.

    Additional Manufacturer Narrative · 0

    LOT 208569 (1): DEVICE RETURNED 19 APRIL 2023. LOT 212228 (1): DEVICE RETURNED 19 APRIL 2023.

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF Q1 2023 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES TWO INSTANCES OF INTRAOPERATIVE VLIFT EXPANDER INSIDE SHAFT FRACTURE.

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF Q1 2023 RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THIS REPORT CAPTURES TWO INSTANCES OF INTRAOPERATIVE VLIFT EXPANDER INSIDE SHAFT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566717 VLIFT INSIDE SHAFT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER SPINE-US 48300210 UNKNOWN 07613327267020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown