BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDFUSE RESET PEDICLE SCREW

    MDR report key: 3909300 · Received February 24, 2014

    Report

    Report Number
    3005977257-2014-00002
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 24, 2014
    Report Date
    February 12, 2014
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVISION SURGERY, WHICH DISCOVERED THE BROKEN SCREW, WAS INITIATED TO ADDRESS PATIENT CONDITION. THE RESET SCREW WAS INITIALLY IMPLANTED IN 09/2013. DURING THIS SURGERY, AN INTERBODY WAS NOT IMPLANTED. THE PEDFUSE PACKAGE INSERT (DOC80001, REV. E) STATES THAT PEDFUSE IMPLANTS ARE INTENDED TO BE USED AS AN ADJUNCT TO FUSION AND CAUTIONS THAT THE DEVICE SYSTEM IS NOT INTENDED TO BE USED AS THE SOLE MEANS OF SPINAL SUPPORT. IT ACKNOWLEDGES THAT USE OF THE PRODUCT WITHOUT BONE GRAFT OR IN CASES OF NON-FUSION CAN CAUSE BREAKAGE OF THE DEVICE. REFER TO THE HIGHLIGHTED EXCERPT OF THE PEDFUSE PACKAGE INSERT (DOC80001, REV. E) ON PAGE 3 OF THE REPORT. THE ENGINEERING EVALUATION OF THE RETURNED RESET IMPLANT CONCLUDED THAT THE IMPLANT BREAKAGE WAS DUE TO EXCESSIVE FORCE AS SEEN BY INCREASED LOAD AND FATIGUE PRECIPITATED BY THE ABSENCE OF THE INTERBODY. THIS CONCLUSION IS SUPPORTED BY THE CLINICAL SCENARIO REPORTED BY THE FIELD REPRESENTATIVE. PEDFUSE PACKAGE INSERT (DOC80001 REV. E). PLEASE NOTE INDICATIONS OF USE AND THE PRECAUTIONS REGARDING IMPLANT USE WITHOUT AN INTERBODY, HIGHLIGHTED BELOW. INDICATIONS: THE PEDFUSE PEDICLE SCREW SYSTEM IS INTENDED TO PROVIDE IMMOBILIZATION AND STABILIZATION OF SPINAL SEGMENTS IN SKELETALLY MATURE PATIENTS AS AN ADJUNCT TO FUSION IN THE TREATMENT OF THE FOLLOWING ACUTE INSTABILITIES OR DEFORMITIES OF THE THORACIC, LUMBAR, AND SACRAL SPINE: PRECAUTION: THE IMPLANTATION OF PEDICLE SCREW SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS PEDICLE SCREW SPINAL SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT. A SUCCESSFUL RESULT IS NOT ALWAYS ACHIEVED IN EVERY SURGICAL CASE. THIS FACT IS ESPECIALLY TRUE IN SPINAL SURGERY WHERE MANY EXTENUATING CIRCUMSTANCES MAY COMPROMISE THE RESULTS. THIS DEVICE SYSTEM IS NOT INTENDED TO BE THE SOLE MEANS OF SPINAL SUPPORT. USE OF THIS PRODUCT WITHOUT A BONE GRAFT OR IN CASES THAT DEVELOP INTO A NON-UNION WILL NOT BE SUCCESSFUL. NO SPINAL IMPLANT CAN WITHSTAND BODY LOADS WITHOUT THE SUPPORT OF BONE. IN THIS EVENT, BENDING, LOOSENING, DISASSEMBLY AND/OR BREAKAGE OF THE DEVICE(S) WILL EVENTUALLY OCCUR.

    Description of Event or Problem · 1

    DURING A REVISION SURGERY DUE TO PATIENT CONDITION, THE SURGEON NOTICED THAT A RESET PEDICLE SCREW, WHICH HAD BEEN IMPLANTED WITHOUT A CORRESPONDING INTERBODY DURING A PRIOR SURGERY ON (B)(6) 2013, WAS BROKEN. THE SCREW HAD BROKEN AT THE BASE OF THE TULIP HEAD RESULTING IN TWO PIECES. THE SURGEON SUCCESSFULLY REMOVED BOTH PIECES OF THE BROKEN SCREW AND REPLACED IT WITH A SLIGHTLY LARGER SCREW TO COMPLETE THE CONSTRUCT. THIS INCIDENT RESULTED IN NO SIGNIFICANT DELAY TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114546 PEDFUSE RESET PEDICLE SCREW PEDICLE SCREW MNI SPINEFRONTIER, INC. 01-80046-40 336406-000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention