BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMESH

    MDR report key: 18664030 · Received February 7, 2024

    Report

    Report Number
    2135156-2024-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    January 9, 2024
    Report Date
    February 7, 2024
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    LXH
    PMA / PMN Number
    DEN200010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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) 2024. WHILE CONDUCTING THE DISCECTOMY, A PORTION OF AN INSTRUMENT BROKE OFF IN THE DISC SPACE. ONE PIECE WAS SUCCESSFULLY REMOVED; HOWEVER, THE OTHER PORTION WAS UNRETRIEVABLE DUE TO ITS LATERAL POSITIONING. THE SURGEON OPTED TO LEAVE THE PIECE OF INSTRUMENT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192808 OPTIMESH SHORT ARTICULATING CURETTE LXH SPINEOLOGY INC. UT20039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other