BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYSPINE MC VERTEBRA L04

    MDR report key: 7666246 · Received July 6, 2018

    Report

    Report Number
    3005180920-2018-00486
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    June 7, 2018
    Report Date
    July 6, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PQC
    UDI-DI
    07630040717298
    PMA / PMN Number
    K173472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    LOT 00683S: (B)(4) ITEMS MANUFACTURED AND RELEASED 11 MAY 2018. EXPIRATION DATE: 2018-10-17 NO ANOMALIES FOUND RELATED TO THE ISSUE. OTHER DEVICES INVOLVED ALL OF THE SAME LOT: REFERENCE 7.0705 (K173472) MYSPINE MC VERTEBRA L05; REFERENCE 7.0724 (K173472) MYSPINE MC DRILL BASED GUIDE L04; REFERENCE 7.0425 (K173472) MYSPINE MC DRILL BASED GUIDE L05. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS (B)(4) ON 06 JULY 2018: L4-L5 CBT STABILIZATION WAS PERFORMED USING PATIENT SPECIFIC GUIDES. THE FINAL POSITION OF THE SCREWS IS NOT SATISFACTORY, AND DIFFERENT FROM PLANNING. WITH THE ELEMENTS AT HAND, NO FURTHER CONCLUSION CAN BE DRAWN. WE ARE UNABLE TO IDENTIFY A CLINICAL CAUSE FOR THE EVENT. INVESTIGATION PERFORMED BY PATIENT MATCH DEPARTMENT ON 06 JUNE 2018; OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. ON 06 JULY 2018 THEY PERFORMED A FURTHER INVESTIGATION AND AS A RESULT THEY REPORTED: THE FINAL TRAJECTORIES OF THE SCREWS IMPLANTED DON'T REFLECT THE PLANNED ONE. THE PLANNING WAS MODIFIED AND VALIDATED BY THE SURGEON AS SAID IN THE PREVIOUS ANALYSIS. THE ENTRY POINTS ARE CONFORM TO THE PROTOCOL AND ARE POSITIONED IN A FLAT ZONE.

    Description of Event or Problem · 1

    THE SURGERY WAS PERFORMED ON (B)(6) WITH MYSPINE MC GUIDE. WHEN THE SURGEON CHECKED THE CT IMAGE ON (B)(6), HE NOTICED THAT THE PEDICLE SCREWS WERE INSERTED IN A DIFFERENT PLACE IN COMPARISON WITH THE PLANNING. ONE OF THE PEDICLE SCREW PROTRUDES LATERALLY AND THE OTHER ONE MEDIALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508614 MYSPINE MC VERTEBRA L04 SURGICAL INSTRUMENT FOR SPINE PQC MEDACTA INTERNATIONAL SA 00683S 07630040717298

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other