BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLIF HIVE-T INTERBODY SPACER

    MDR report key: 9247999 · Received October 28, 2019

    Report

    Report Number
    3013462427-2019-00001
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    September 30, 2019
    Report Date
    October 25, 2019
    Manufacturer
    HD LIFESCIENCES LLC
    Product Code
    MAX
    UDI-DI
    00817493020824
    PMA / PMN Number
    K170676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: REVIEW OF DEVICE HISTORY RECORDS FOUND DEVICES MET ALL ACCEPTANCE CRITERIA. REVIEW OF DEVICE USAGE FOUND NO ISSUES WITH DEVICES FROM THE SAME LOT OR OTHER LOT NUMBERS. BENCH TESTING OF A SIMILAR DEVICE IDENTIFIED THE FAILURE CONDITION ONLY WHEN EXPOSED TO EXCESSIVE TORQUE FORCE. DEVICES OF THIS SIZE ARE NOT TO BE INSERTED AND ROTATED PER SYSTEM LABELING AND TRAINING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BROKE INTO TWO PIECES DURING AN ATTEMPT TO ROTATE THE DEVICE INTO POSITION IN THE DISC SPACE. THE PROXIMAL PIECE OF THE DEVICE WAS COMPLETELY REMOVED. THE DISTAL PIECE OF THE DEVICE WAS REPORTED TO BE IN THE DESIRED POSITION IN THE DISC SPACE AND WAS LEFT IN THE PATIENT AT THE SURGEON'S DISCRETION. RESULTED IN NO DELAY IN SURGERY AND NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042613 TLIF HIVE-T INTERBODY SPACER INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT MAX HD LIFESCIENCES LLC 03-A-0006-4010 116307 00817493020824

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR