BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDFUSE

    MDR report key: 17852446 · Received October 2, 2023

    Report

    Report Number
    3005977257-2023-00009
    Event Type
    Injury
    Date Received
    October 2, 2023
    Manufacturer
    LESSPINE INNOVATIONS
    Product Code
    MNI
    UDI-DI
    00190361028185
    PMA / PMN Number
    K143377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL INTERVENTION WAS REQUIRED TO AVOID SERIOUS INJURY. MEDICAL INTERVENTION IN THIS SURGERY WAS REMOVAL OF THE LOOSE METAL DEBRIS VIA FORCEPS AND IRRIGTION FROM THE INCISION SITE. THE TWO DAMAGED SET SCREWS SHOW THAT ONE THREAD WAS ENGAGED ON ONE SIDE OF THE PEDICLE SCREW TULIP. THE SHEARED THREAD INDICATES A HIGH FORCE BEING APPLIED FROM THE ROD DURING FINAL TIGHTENING. THE ROD WAS NOT FULLY REDUCED AS INDICATED BY THE TOP THREAD OF THE SET SCREW BEING INTACT. THE ROD REDUCER IMPROVED THE SITUATION WHEN USED AFTER THE TWO SET SCREWS WERE DAMAGED. THIS ALLOWED THE THIRD SET SCREW AND SECOND PEDICLE SCREW TO SUCCESSFULLY FINAL TIGHTEN. THE PEDICLE SCREW THAT WAS REMOVED IS INTACT WITH SCRATCHES ON THE THREADS FROM THE SHEARED SET SCREW. THE 9.5N-M TORQUE HANDLE IS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    THE EVENT TOOK PLACE DURING A 2 LEVEL PEDICLE SCREW CONSTRUCT L3-L5 USING MIDLINE TECHNIQUE. TWO SET SCREW THREADS SHEARED DURING FINAL TORQUE STEP ON THE SAME PEDICLE SCREW. L5 SCREW WAS WHERE THE ISSUE OCCURED. ALL SET SCREWS WERE PLACED; THE ORDER OF FINAL TIGHTENTING IS UNKNOWN. THE FIRST FAILED SET SCREW WAS REMOVED AND REPLACED WITH A SECOND SET SCREW. AFTER THE SECOND SET SCREW FAILED, BOTH THE PEDICLE SCREW AND SET SCREW WERE REMOVED AND REPLACED. THE ROD REDUCER WAS USED PRIOR TO FINAL TIGHTENING THE THIRD SET SCREW. THE THIRD SET SCREW AND SECOND PEDICLE SCREW WERE SUCCESSFUL. SHEARED MATERIAL FROM THE SET SCREWS WERE REMOVED WITH FORCEPS AND IRRIGATED WITH ANTIBIOTICS. NO PATIENT HARM AND THE SURGERY WAS COMPLETED AS INTENDED. SET SCREW, PEDICLE SCREW AND TORQUE HANDLE WERE RETURNED FOR EVALUATION. 01-80325, (B)(6) SET SCREW (QTY 2). 01-80169-45R, IE18 PEDICLE SCREW. 11-80032, EH21 9.5N-M TORQUE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154986 PEDFUSE PEDICLE SCREW SYSTEM MNI LESSPINE INNOVATIONS 01-80325 00190361028185

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention