BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDUCTION CANNULATED PEDICLE SCREW 5X45

    MDR report key: 16395234 · Received February 17, 2023

    Report

    Report Number
    3005180920-2023-00075
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 20, 2023
    Report Date
    February 17, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030847080
    PMA / PMN Number
    K153664
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL ITEMS INVOLVED IN THE EVENT: MYSPINE 7.0722 MYSPINE MC DRILL BASED GUIDE L02 (K173472) LOT. 08794S. MYSPINE 7.0702 MYSPINE MC VERTEBRA L02 (K173472) LOT. 08794S. BATCH REVIEW PERFORMED ON 30 JANUARY 2023. LOT 08794S: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 JANUARY 2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. MYSOLUTION DEPARTMENT ANALYSIS. OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. GUIDES WERE REPRINTED AND TESTED WITH POSITIVE RESULTS. IN PARTICULAR, THE L02 GUIDE IS VERY STABLE, THANKS IN PART TO THE CRANIAL ARCH, AND CONSISTENT WITH ALL THE PREFERENCES REQUESTED BY THE SURGEON. THE GUIDE USED DURING SURGERY AND THE BONE MODEL WERE SENT BACK FOR ANALYSIS AND WERE TESTED WITH POSITIVE RESULTS: THE FITTING IS STABLE AND UNIVOCAL WITHOUT ANY SLIPPING PROBLEMS. IT IS EVIDENT THE CORRECT FIT WITH THE TRAJECTORY OF THE HOLES ('LEFT HOLE' AND 'RIGHT HOLE') AND THE CORRECT POSITIONING OF THE PADS IN 3 DIFFERENT VIEWS.

    Description of Event or Problem · 0

    DURING SURGERY, IT WAS DIFFICULT TO FIT THE L2 GUIDE TO THE BONE. DELAY TIME WAS 30MIN. THE SURGEON CONFIRMED THAT THE SCREW HAD COME OFF BY POST-OP CT IMAGE. A SECOND SURGERY WAS IMMEDIATELY PERFORMED, THE SCREW WAS REMOVED, AND REFIXATION WAS PERFORMED. THE SPINOUS PROCESS WAS EXCISED AS INDICATED IN THE PLANNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135105 REDUCTION CANNULATED PEDICLE SCREW 5X45 SPINE PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 03.52.712 07630030847080

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention