BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANQUIL-L

    MDR report key: 17725926 · Received September 11, 2023

    Report

    Report Number
    3011390763-2022-00002
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    April 23, 2020
    Report Date
    January 16, 2022
    Manufacturer
    NEXUS SPINE, LLC
    Product Code
    MAX
    PMA / PMN Number
    181702
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: INSERTER SHOWED SIGNS OF BENDING/STRESS NEAR TIP INDICATING THAT THE INSERTER MAY HAVE NOT BEEN FULLY TIGHTENED OR HAD PARTIALLY LOOSENED DURING INSERTION. OTHER REMARKS: COMPLAINT FOLLOW-UP FROM REMEDIATION ACTIVITIES RESULTING IN LATE FILING.

    Description of Event or Problem · 0

    SURGICAL INSTRUMENT TIP LEFT IN IMPLANT IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062771 TRANQUIL-L INSERTER MAX NEXUS SPINE, LLC 822001 33940

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other