BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYSPINE STANDARD DRILL GUIDE T07

    MDR report key: 8599632 · Received May 10, 2019

    Report

    Report Number
    3005180920-2019-00356
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 10, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MNI
    UDI-DI
    07630030856556
    PMA / PMN Number
    K132788
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 MAY 2019: LOT 01443S: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-APR-2019. EXPIRATION DATE: 2019-09-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: ACCORDING TO THE REPORT, THE SURGERY HAS BEEN DELAYED DUE TO ADDITIONAL PREPARATION REQUIRED IN ORDER TO POSITION THE GUIDES. THIS WAS CAUSED BY DEFORMITY AND THORACIC DIMENSIONS THAT COULD NOT BE TAKEN INTO CONSIDERATION AT THE TIME OF GUIDE PLANNING. THE SURGERY WAS COMPLETED WITH THE USE OF THE GUIDES. THE GUIDES WERE MANUFACTURED AS CUSTOM MADE DEVICES ACCORDING TO THE SPECIFICATIONS OF THE PRESCRIPTION ISSUED BY THE SURGEON; NO UNCONFORMITY TO THE PRESCRIPTION COULD BE IDENTIFIED. HENCE, THE SURGICAL DELAY, DEEMED NOT CRITICAL BY THE SURGEON, WAS NOT CAUSED BY A DEFECT OF THE DEVICE. MYSOLUTION DEPARTMENT ANALYSIS: IT IS CONFIRMED THAT THERE WAS A COSTAL INTERFERENCE BETWEEN THE MYSPINE STANDARD GUIDES FROM T07 TO T10 AND THE PATIENT'S RIBS. AS PER PROCEDURE IN FORCE THE INTERFERENCE CONTROL IS NOT PERFORMED BETWEEN STANDARD MYSPINE GUIDES AND RIBS. ADDITIONAL INSTRUMENT INVOLVED (K132788): 7.0108 MYSPINE DRILL GUIDE T08, LOT: 01443S; 7.0109 MYSPINE DRILL GUIDE T089, LOT: 01443S; 7.0110 MYSPINE DRILL GUIDE T10, LOT: 01443S.

    Description of Event or Problem · 1

    STANDARD MYSPINE GUIDES FROM T7 TO T10 DIDN'T FIT WELL WITH THE CORRESPONDING VERTEBRAE IN SITU DUE TO COSTAL INTERFERENCE. THE SURGEON HAD TO PREPARE ALSO THE THORACIC COSTOTRANSVERSE JOINT IN ORDER TO APPLY THE GUIDE. SOME MATERIAL WAS REMOVED FROM THE RIBS TO ALLOW THE USE OF THE GUIDES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 20 MINUTES CONSIDERED AS NOT CRITICAL BY THE MEDICAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391686 MYSPINE STANDARD DRILL GUIDE T07 SURGICAL INSTRUMENT FOR SPINE SURGERY MNI MEDACTA INTERNATIONAL SA 01443S 07630030856556

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other