BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELINE

    MDR report key: 19180438 · Received April 25, 2024

    Report

    Report Number
    19180438
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    March 26, 2024
    Report Date
    May 20, 2024
    Manufacturer
    NUVASIVE, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER FOLLOW UP REQUEST THIS IS A SECOND FOLLOW UP TO TWO PREVIOUS RELATED REPORTS 2031966-2024-00136 AND (B)(4). OTHER CHANGES LISTED ON SECTIONS B4, D2, D6 G3, G6, H2, H10.

    Description of Event or Problem · 0

    CORRECTED INFORMATION LISTED ON SECTION H10.

    Description of Event or Problem · 0

    NUVASIVE FINAL LOCKSCREW DRIVER TIP BROKE OFF INSIDE SET SCREW AS SURGEON WAS ATTEMPTING TO TIGHTEN SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660360 RELINE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male