BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYSPINE UNILATERAL LEFT GUIDE S01

    MDR report key: 20031372 · Received August 22, 2024

    Report

    Report Number
    3005180920-2024-00722
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 11, 2024
    Report Date
    August 22, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PQC
    UDI-DI
    07630345786586
    PMA / PMN Number
    K231483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLANNING REVIEW AND VISUAL INSPECTION PERFORMED BY MYSOLUTION DEPARTMENT. OUR ANALYSIS OF THE MYSPINE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. THE FITTING IS VERY GOOD, THE GUIDES ARE STABLE AND HAVE A UNIVOCAL POSITIONING. THE RESULT IS IDENTICAL FROM THOSE REPRINTED PREVIOUSLY IN MEDACTA HEADQUARTER, I.E., FULLY COMPLIANT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 AUGUST 2024 LOT 13813S: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUL-2024. EXPIRATION DATE: 2024-DEC-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. OTHER PRODUCTS INVOLVED IN THE EVENT: MYSPINE 7.1057 MYSPINE UNILATERAL RIGHT GUIDE S01 (K231483) LOT. 13813S. MYSPINE 7.0726 MYSPINE-MC DRILL GUIDE S01 (K173472) LOT. 13813S. MYSPINE 7.1055 MYSPINE UNILATERAL RIGHT GUIDE L05 (K231483) LOT. 13813S. MYSPINE 7.1025 MYSPINE UNILATERAL LEFT GUIDE (K231483) L05 LOT. 13813S. MYSPINE 7.0555 MYSPINE LP DRILL PILOT GUIDE L05 (K153273) LOT. 13813S. NOTE: THE COMPLAINT WAS REPORTED LATE (OVER 30 DAYS) DUE TO HUMAN ERROR. TODAY, AUGUST 21, 2024, THE ERROR WAS NOTICED AND THE COMPLAINT WAS REPORTED.

    Description of Event or Problem · 0

    THE TRAJECTORY OBTAINED USING MYSPINE UNILATERAL GUIDES AT S01 AND L5 WAS INCORRECT. HE BEGAN AT S1 AND ACCORDING TO HIM HE DID A THOROUGH SOFT TISSUE DISSECTION AND WAS SATISFIED THAT THE IN SITU FIT WAS JUST AS SOLID AS THE FIT ON THE VERTEBRAL MODEL. HE INTRODUCED THE DRILL AND TOOK A FLUORO SHOT, INDICATING THE TRAJECTORY WAS INCORRECT. HE SPENT ALMOST 30-40 MINUTES TRYING TO GET THE GUIDE POSITIONED CORRECTLY BUT WAS CONVINCED THAT THE GUIDE WAS PROBABLY PRINTED INCORRECTLY. HE THEN MOVED ONTO THE LEFT L5 GUIDE. AFTER A THOROUGH SOFT TISSUE DISSECTION AND AN INDICATED OSTEOTOMY, HE DOCKED THE GUIDE AND AFTER INTRODUCING THE DRILL AND TAKING A FLOURO SHOT WE SAW THAT THE TRAJECTORY WAS INCORRECT. HE CONTINUED TO DO MORE DISSECTION AND TOOK A SECOND SHOT AFTER DOCKING THE GUIDE BUT THE TRAJECTORY WAS STILL OFF. HE DECIDED AT THAT POINT TO FREEHAND THE SCREWS. THE SURGEON DECIDED TO PLACE THE SCREWS FREEHAND. THE ISSUE CAUSED 30-40 MINUTES DELAY; TOTAL SURGERY TIME 281 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952223 MYSPINE UNILATERAL LEFT GUIDE S01 SPINE SCREW PLACEMENT GUIDE PQC MEDACTA INTERNATIONAL SA 13813S 07630345786586

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Other