BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND BRACE

    MDR report key: 22699756 · Received August 4, 2025

    Report

    Report Number
    2135156-2025-00002
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 3, 2025
    Report Date
    August 1, 2025
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    LXH
    UDI-DI
    M7401001285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OF ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO AN INJURY OR DEATH.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE ON (B)(6) 2025. DURING THE SURGICAL PROCEDURE WHILE FILLING THE MESH IMPLANT, IMAGING CONFIRMED PORTAL TUBE ADVANCEMENT ANTERIORLY THROUGH THE ANNULUS. THE PORTAL TUBE WAS RETRACTED AND THE MESH IMPLANT COMPONENT REMOVED. THE SURGEON CONFIRMED NO PATIENT INJURY OR CONSEQUENCE AS A RESULT OF THE ANNULUS BREACH. AN ALTERNATE INTERVERTEBRAL FUSION DEVICE AND FIXATION WERE PLACED TO COMPLETE THE SURGICAL PROCEDURE WITHOUT PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585046 HAND BRACE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SPINEOLOGY INC. M7401001285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other