BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUST LT MUST LT 15MM SHORT - PEDICLE SCREW Ø6X40 CANN

    MDR report key: 12743398 · Received November 3, 2021

    Report

    Report Number
    3005180920-2021-00844
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 4, 2021
    Report Date
    November 3, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971278387
    PMA / PMN Number
    K203482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 14 OCTOBER 2021: LOT 2024304: (B)(4). EXPIRATION DATE: 2026-03-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL DEVICES INVOLVED: BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 14 OCTOBER 2021: MUST LT 03.57.024 MUST LT 15MM SHORT - PEDICLE SCREW Ø6X40 CANN (K203482) LOT 2122304: (B)(4). EXPIRATION DATE: 2026-04-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). VISUAL INSPECTION PERFORMED ON 19 OCTOBER 2021 BY MEDACTA R&D SPINE MANAGER: THE SURGEON COULDN`T INSERT THE PEDICLE SCREW INTO THE PATIENT`S BONE DESPITE HE PERFORMED TAPPING. INTERNALLY WE TESTED THE IMPLANTS PRESENT IN OUR WAREHOUSE WITH THE SAME LOT NUMBER OF THE IMPLANT INVOLVED AND, WE TESTED THE SAME SEMI-FINISHED SCREWS (SAME BATCH NUMBER) OF THE IMPLANT INVOLVED TRYING TO INSERT THEM ON THE SAWBONES FOLLOWING THE SAME SURGICAL PROCEDURE USING THE TAP AND WITHOUT USING THE TAP. THE RESULTS OBTAINED ARE POSITIVE, ALL THE SCREWS ARE SCREWED WITHOUT ANY SORT OF PROBLEM. THE SAME TEST HAS BEEN PERFORMED WITH THE IMPLANTS RECEIVED AND THE RESULTS ARE THE SAME. NO ISSUE DETECTED DURING INSERTION. WITH THE INFORMATION RECEIVED AND ACCORDING TO THE RESULTS OBTAINED WITH THE INTERNAL TESTS IS NOT POSSIBLE TO DESCRIBE A ROUTE CAUSE OF THE COMPLAINT.

    Description of Event or Problem · 0

    THE SURGEON COULDN`T INSERT THE PEDICLE SCREW INTO THE PATIENT`S BONE DESPITE HE PERFORMED TAPPING. THE SAME PROBLEM OCCURRED WITH TWO OTHER SCREWS OF THE SAME SIZE. FINALLY, HE USED 7MM SCREW AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 1 HOUR OF DELAY AND A TOTAL SURGERY TIME OF 3.5H. THE SURGERY WAS L4/L5 FUSION. THIS EVENT OCCURRED DURING INSERTING L5 SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640389 MUST LT MUST LT 15MM SHORT - PEDICLE SCREW Ø6X40 CANN SPINE PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 03.57.024 2024304 07630971278387

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other