BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYSPINE

    MDR report key: 20320898 · Received September 27, 2024

    Report

    Report Number
    3005180920-2024-00768
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 28, 2024
    Report Date
    October 31, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PQC
    UDI-DI
    07630040717571
    PMA / PMN Number
    K173472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 SEPT 2024 LOT 14461S: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-AUG-2024. EXPIRATION DATE: 2025-02-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. PLANNING REVIEW AND ANALYSIS PERFORMED BY MY SOLUTION DEPARTMENT: OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. WE REPRODUCED THE GUIDES AND THE FITTING OF ALL THE LEVELS ARE CONFORM. THE GUIDES ARE COMPLETELY STABLE. FOR ALL CASES IT IS NOT POSSIBLE TO DEVELOP A GUIDE ON THE WRONG PATIENT AS DURING IMAGE QUALITY CONTROL WE ALSO HAVE THAT CHECK TO DO. IF THE CASE CODE HAS ANY DISCREPANCIES FROM THE DATA THAT IS FILLED BY THE RADIOLOGY CENTRE DURING CT ACQUISITION, WE ALWAYS ASK FOR CONFIRMATION FROM SALES AND UNTIL WE RECEIVE IT THE CASE WILL REMAIN BLOCKED. ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON 04 SEPT 2024 ON PEDICLE SCREW 03.58.232 MUST MC SCREW Ø5.5X30 CANNULATED (K210427) LOT. 2325059 LOT 2325059: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2023. EXPIRATION DATE: 2028-09-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, XX ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON 04 SEPT 2024 ON PEDICLE SCREW 03.58.232 MUST MC SCREW Ø5.5X30 CANNULATED (K210427) LOT. 2325059 LOT 2325059: 50 ITEMS MANUFACTURED AND RELEASED ON 13-OCT-2023. EXPIRATION DATE: 2028-09-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ONLY THIS ITEM OF THIS LOT HAS BEEN SOLD. VISUAL INSPECTION PERFORMED BY R&D DEPARTEMENT: THE IMPLANT (PEDICLE SCREW MUST MC SCREW Ø5.5X30 CANNULATED) IS CONFORM. THE EXTERNAL DIAMETER AND THE THREAD ARE CONFORM. THE ROOT CAUSE COULD NOT BE ASSOCIATED TO THE IMPLANT. IT CAN BE CONFIRMED THAT THE VERTEBRAL MODELS RECEIVED CORRESPOND TO THE PATIENT'S ANATOMY FOR WHICH CT SCAN HAS BEEN RECEIVED. NO ISSUES DETECTED. ROOT-CAUSE DESCRIPTION: THE IMPLANT AND THE VERTEBRAL MODELS ARE CONFORM. THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE AND THE MYSOLUTION PLANNING REVIEW DID NOT FIND ANY ANOMALY IN THE PROCESS. THE ISSUE MAY RELATE TO UNIQUE CIRCUMSTANCES PRESENT ONLY AT THE TIME OF APPLICATION, BUT NO CONFIRMATION CAN BE MADE AT THIS TIME. CORRECTION: - D1 BRAND NAME CORRECTED - D4 MODEL NUMBER INSERTED IN THE CORRECT POSITION - BATCH REVIEW OF LOT. 2325059 CORRECTED. DEVICE EVALUATION: - DEVICES RETURNED ON 10.01.2024 - VISUAL INSPECTION PERFORMED.

    Description of Event or Problem · 0

    SPINAL FIXATION WAS PERFORMED AT L4-S1 WITH MYSPINE MC GUIDES. THE SURGEON FELT THAT THE GUIDE DID NOT FIT THE VERTEBRAL BODY AT L4-S1. THE SURGEON USED THE GUIDES ANYWAYS, EXCEPT FOR THE RIGHT SIDE OF L5, WHERE HE INSERTED THE PEDICLE SCREW (5.5 X 30MM) BY FREEHAND. AFTER DECOMPRESSION, THE PEDICLE SCREW LOOSEN, SO THE RIGHT SIDE OF L5 WAS SKIPPED. THE SURGERY WAS COMPLETED WITH 30 MIN DELAY (TOT TIME 5 HOURS). THE SURGEON SUSPECTS THAT THE GUIDES ARE FOR THE WRONG PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709063 MYSPINE SPINE SURGICAL GUIDES PQC MEDACTA INTERNATIONAL SA 7.0726 14461S 07630040717571

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Other