BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYSPINE MYSPINE MC DRILL BASED GUIDE L04

    MDR report key: 9710937 · Received February 14, 2020

    Report

    Report Number
    3005180920-2020-00059
    Event Type
    Injury
    Date Received
    February 14, 2020
    Date of Event
    January 16, 2020
    Report Date
    March 19, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PQC
    UDI-DI
    07630040717533
    PMA / PMN Number
    K173472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE MYSPINE BONE MODELS (REF. 7.0704-7.0705) AND THE MYSPINE GUIDES (REF. 7.0724-7.0725) OF L4 AND L5 RESPECTIVELY HAVE BEEN INSPECTED FOR A DEEPER INVESTIGATION OF THE COMPLAINT. THE FITTING BETWEEN THE BONE MODELS AND THE GUIDES OF L4 AND L5 RESULTS ARE FULLY CONFORMING: THE GUIDE CAN BE DOCKED AND REMOVED FROM THE BONE MODEL WITHOUT ANY ISSUE (SEE IMAGE 1 AND 2 ATTACHED). FURTHERMORE, FROM THE VISUAL INSPECTION, IT CAN BE NOTICED THAT THERE IS NO IMPINGEMENT BETWEEN THE GUIDE AND THE UPPER FACET JOINTS. DUE TO THE FACT, THE FACETS OF THE UPPER VERTEBRAE (L3 FOR L4 GUIDE AND L4 FOR L5 GUIDE) NOT NEEDED TO BE RESECTED.

    Additional Manufacturer Narrative · 1

    PATIENT MATCH PLANNING REVIEW AS PER YOUR REQUEST, WE ANALYZED EACH STEP OF THE MYSPINE PROCESS. IMAGES QC: THE IMAGES WE RECEIVED WERE SUBJECTED TO QUALITY CONTROL, THE RESULT OF WHICH WAS POSITIVE. RECONSTRUCTION: THE RECONSTRUCTION IS PRECISE AND CORRECT, ALL AREAS WERE CLEARLY IDENTIFIABLE. THE RECONSTRUCTED PROFILES FOLLOW ACCURATELY THE CONTOUR OF THE VERTEBRAE: PLANNING: THE SURGEON VALIDATED OUR FIRST PLANNING PROPOSAL. THE GUIDES WERE DESIGNED ACCORDING TO THE TRAJECTORY OF THE SCREWS IN THE PLANNING VALIDATED BY THE SURGEON. CONCLUSIONS OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. ADDITIONAL DEVICE INVOLVED: MYSPINE 7.0725 MYSPINE MC DRILL BASED GUIDE L05 (K173472) LOT. 02494S. ALL THE ITEMS INVOLVED ARE RELATED TO LOT NUMBER 02494S BATCH REVIEW PERFORMED ON 28 JANUARY 2019: LOT 02494S: (B)(4) GUIDES MANUFACTURED AND RELEASED ON 02-JAN-2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM.

    Description of Event or Problem · 1

    THE SURGEON WAS NOT ABLE TO SET THE MYSPINE MC GUIDE CORRECTLY AT L4- L5. THE SURGEON FINISHED THE SURGERY WITHOUT USING THE MYSPINE MC GUIDE. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 1 HOUR. TOTAL SURGERY TIME ABOUT 200 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174262 MYSPINE MYSPINE MC DRILL BASED GUIDE L04 DRILL GUIDE FOR SPINE SURGERY PQC MEDACTA INTERNATIONAL SA 02494S 07630040717533

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Other