BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYSPINE-MC DRILL GUIDE L03

    MDR report key: 17010038 · Received May 26, 2023

    Report

    Report Number
    3005180920-2023-00391
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    April 13, 2023
    Report Date
    May 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PQC
    UDI-DI
    07630040717519
    PMA / PMN Number
    K173472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 09341S: 1 ITEM MANUFACTURED AND RELEASED ON (B)(6) 2023. EXPIRATION DATE: 2023-09-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. PATIENT MATCH PLANNING REVIEW PERFORMED BY MY SOLUTION: OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. WE REPRINTED THE GUIDES AND BONE MODELS AND WE CHECKED THE FITTING AND IT CONFORMED. WE ALSO SPOKE WITH THE SURGEON (WHO WAS VISITING CSP) AND HE TOO CONFIRMED THAT THE FITTING WAS OK AND THAT HE FOUND IT DIFFICULT BECAUSE IT WAS A COMPLICATED CASE DUE TO THE PATIENT'S MORPHOLOGY ADDITIONAL INVOLVED DEVICE BATCH REVIEW PERFORMED ON (B)(6) 2023 ON MYSPINE 7.0723 MYSPINE-MC DRILL GUIDE L03 (K173472) LOT. 09408S LOT 09408S: 1 ITEM MANUFACTURED AND RELEASED ON (B)(6) 2023. EXPIRATION DATE: 2023-09-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM.

    Description of Event or Problem · 0

    DURING THE PRIMARY SPINE SURGERY, THE MYSPINE GUIDES DID NOT FIT PROPERLY ON THE VERTEBRAE AFTER DISSECTION. THE SURGEON USED FLUOROSCOPY TO COMPLETE THE CASE. THERE WAS A 1 HOUR AND 30 MINUTE DELAY DUE TO GUIDES ISSUE AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE SURGERY WAS COMPLETED SUCCESSFULLY. TOTAL SURGERY TIME: 3.5 TO 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886092 MYSPINE-MC DRILL GUIDE L03 SPINE MYSPINE DRILL GUIDE PQC MEDACTA INTERNATIONAL SA 7.0723 09341S 07630040717519

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention