BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUST MINI CANNULATED POLYAXIAL SCREW 4.0 X 30 FULL THREAD + NUT

    MDR report key: 15092005 · Received July 25, 2022

    Report

    Report Number
    3005180920-2022-00567
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    June 30, 2022
    Report Date
    November 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKG
    UDI-DI
    07630030863882
    PMA / PMN Number
    K171369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 JULY 2022: LOT 2020760: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2020. EXPIRATION DATE: 2025-05-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA SPINE R&D PROJECT MANAGER: DURING THE VISUAL INSPECTION ON RETRIEVED IMPLANTS IT WAS OBSERVED THAT THE SET-SCREW WERE STILL INTACT WITH NO SIGN OF THREADING DEFORMATION OR BREAKAGE. A SAWBONE WAS PERFORMED ON THE RETRIEVED SET-SCREW COMPONENT IN ORDER TO VERIFY THE OVERALL FUNCTIONALITY WHEN SECURED WITH THE ASSOCIATED POLYAXIAL SCREW COMPONENT. DURING THE TEST IT WAS OBSERVED A SLIGHT FRICTION AT THE THREADING INTERFACE DURING ADVANCING. HOWEVER IT WAS POSSIBLE TO POSITION AND SECURE THE SET-SCREWS AS PER STANDARD PROCEDURE UNDER 3NM TORQUE. REVERSE PROCEDURE WAS SUCCESSFULLY PERFORMED TO REMOVE THE SET-SCREW ALL THE WAY. THE TEST WAS SUCCESSFULLY PERFORMED THREE TIME WITH NO EVIDENCE OF IMPLANTS FAILURE. BASED ON TEST RESULT, IT WAS POSSIBLE TO SECURE AND REMOVE THE SET-SCREW DEFINABLY, ACCORDING TO THE STANDARD PROCEDURE AND AVAILABLE INSTRUMENTATION. THE REASON OF LOOSENING IS UNKNOWN. IT IS SUPPOSED THAT THE SET-SCREW WAS NOT FULLY SECURED DURING THE FINAL PROCEDURE.

    Description of Event or Problem · 0

    AT ABOUT 5 MONTHS AFTER THE PRIMARY, IT WAS OBSERVED THAT THE SET SCREW INSERTED TO THE C2 SCREW CAME OFF. THE SURGEON REVISED THE SCREW IN C2. AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532997 MUST MINI CANNULATED POLYAXIAL SCREW 4.0 X 30 FULL THREAD + NUT SPINE CANNULATED SCREW'S SET SCREW NKG MEDACTA INTERNATIONAL SA 03.75.210 2020760 07630030863882

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other