BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUST MINI POLYAXIAL SCREW 3.5 X 18 FULL THREAD + NUT

    MDR report key: 15679054 · Received October 27, 2022

    Report

    Report Number
    3005180920-2022-00807
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    October 4, 2022
    Report Date
    December 22, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKG
    UDI-DI
    07630030863189
    PMA / PMN Number
    K171369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 7 OCTOBER 2022: LOT 2021972: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-SEP-2020. EXPIRATION DATE: 2025-SEP-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 7 OCTOBER 2022: MUST MINI 03.75.005 MUST MINI POLYAXIAL SCREW 3.5 X 20 FULL THREAD + NUT (K171369) LOT 1922080: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-SEP-2019. EXPIRATION DATE: 2024-SEP-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: DURING A MULTI-LEVEL POSTERIOR CERVICAL SPINE STABILIZATION SURGERY, A BONE FRACTURE OCCURS WHILE TIGHTENING A PEDICLE SCREW. NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D MANAGER: BASED ON AVAILABLE INFORMATION, IT WAS UNDERSTOOD THAT THE LAMINA BROKE AFTER THE INSERTION OF THE SCREW, DUE TO THE CONTACT. BONE PREPARATION BY USING THE ASSOCIATED DRILLS AND TAPS IS RECOMMENDED IN ORDER TO EASE THE POSITIONING WHILE PREVENTING POTENTIAL ISSUE THAT COULD LEAD TO BONE FRACTURE. ADDITIONALLY, IT IS NOT UNKNOWN THAT A DEEPER POSITIONING OF SCREW IN THE VERTEBRAE COULD POTENTIAL LEAD TO BONE FAILURE LIKE FRACTURE, IN PARTICULAR WHEN THE BONE DENSITY QUALITY IS NOT OPTIMAL. VISUAL INSPECTION AND A FUNCTIONAL CHECK WAS PERFORMED ON THE RETRIEVED IMPLANT FOR INVESTIGATION: NO EVIDENCE OF DEFECT OR FAILURE WAS OBSERVED. THE SCREW WAS FUNCTIONAL AND INTACT.

    Description of Event or Problem · 0

    DURING SCREW INSERTION ON C7 LAMINA, THE SCREW HEAD HIT THE BONE, AND THE BONE FRACTURED IN FOUR POINTS. THE TRAJECTORY WAS DEFINED FREEHAND AND NO TAPPING WAS PERFORMED (THE SURGEON USED AIR-TOME AND THEN DRILLED WITH 03.75.0014; K-WIRE WAS NOT USED). BOTH SCREWS ON C7 WERE REMOVED AND REPLACED. THE SURGEON CHANGED THE TRAJECTORY OF THE SCREWS AND USED SHORTER SCREWS TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2942744 MUST MINI POLYAXIAL SCREW 3.5 X 18 FULL THREAD + NUT SPINE POLYAXIAL SCREW NKG MEDACTA INTERNATIONAL SA 03.75.004 2021972 07630030863189

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R