BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T HANDLE

    MDR report key: 11783030 · Received May 5, 2021

    Report

    Report Number
    MW5101191
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 14, 2021
    Report Date
    May 3, 2021
    Manufacturer
    SPINAL ELEMENTS INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A POSTERIOR LUMBAR FUSION A SPINAL ELEMENTS T-HANDLE BROKE WHILE OVER THE OPERATIVE SITE. ALL PIECES WERE IMMEDIATELY RECOVERED BY THE SCRUB PERSON AND REMOVED FROM THE STERILE FIELD TO BE SENT TOGETHER TO RISK MANAGEMENT. THE PIECES INCLUDE THE T-HANDLE AND TWO SMALL METAL FRAGMENTS. HANDLE IS LABELLED (B)(4). ROUTINE PROCEDURE X-RAYS TAKEN OF THE SURGICAL SITE SHOW NO RETAINED FRAGMENTS. NO HARM DONE TO THE PATIENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675841 T HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SPINAL ELEMENTS INC. 10091-000 140467

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR