BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. MINI POLYAXIAL SCREW

    MDR report key: 22769926 · Received August 11, 2025

    Report

    Report Number
    3005180920-2025-00753
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    July 17, 2025
    Report Date
    October 1, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKG
    UDI-DI
    07630030863790
    PMA / PMN Number
    K171369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA SPINE R&D PROJECT MANAGER: BASED THE VISUAL INSPECTION ON RETRIEVED DEVICE, NO ANOMALIES WERE OBSERVED AND DETECTED THAT COULD LEAD TO BONE FRACTURE. BONE FRACTURE CAN BE REPORTED AS A CONSEQUENCE OF SPECIFIC VERTEBRA MORPHOLOGY, SPECIFIC SCREW TRAJECTORY AS WELL AS THE CRITICAL CONDITION OF BONE LIKE DESCRIBED IN THE CASE REPORT. IN CONCLUSION, WE CAN SAY THAT T IS NOT UNCOMMON THAT SUCH A BONE FRACTURE OCCURS WHILE ATTEMPTING TO INSERT PEDICLE SCREW IN THE CERVICAL VERTEBRAE. IT IS EXPECTED THAT THE USERS ARE FAMILIAR WITH THE IMPLANT DEVICES AS WELL AS IN DETERMINING THE APPROPRIATE SCREWS TRAJECTORY RELATED TO PARIENT ANATOMY AND BONE CONDITION. NOTE: THE BATCH REVIEW OF 2 SCREWS WAS INSERTED IN THE INITIAL REPORT 3005180920-2025-00753 BECAUSE THEY WERE THE 2 SCREWS AT LEVEL C6, BUT IT IS UNKNOWN TO US AT NOW, WHICH OF THE 2 SCREWS WAS AT THE LEVEL OF THE BONE FRACTURE GENERATED. EDITED FIELDS: H6 H11.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 JULY 2025: LOT: 2459332: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2024. EXPIRATION DATE: 2029-04-06. 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 DEVICE INVOLVED, BATCH REVIEW PERFORMED ON 29 JULY 2025: MUST MINI 03.75.002 MUST MINI POLY. SCREW-FULL THREAD-3.5X14+NUT (STE) (K171369) LOT: 2220379: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-FEB-2022. EXPIRATION DATE: 2027-02-08. 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.

    Description of Event or Problem · 0

    DURING SURGERY FOR METASTATIC SPINAL TUMOR, FIXATION WAS PERFORMED FROM C3 TO C6 USING LATERAL SCREWS. C4-5 WAS SKIPPED DUE TO THE PRESENCE OF A TUMOR. A BONY TUNNEL WAS CREATED USING THE MYSPINE GUIDE, AND AFTER DECOMPRESSION, SCREWS WERE INSERTED. AT THE STAGE OF ROD FIXATION, A FRACTURE OCCURRED AT THE BASE OF THE SCREW AT C6 (L), PROMPTING AN EXTENSION OF THE FIXATION TO BILATERAL C7. ALTHOUGH AN ATTEMPT WAS MADE TO INSERT A PEDICLE SCREW VIA THE LATERAL MASS AT C7 (L), IT INTERFERED WITH THE SPINAL CANAL AND WAS SUBSEQUENTLY REMOVED. A PEDICLE SCREW WAS THEN INSERTED FREEHAND ALONG THE PS TRAJECTORY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171841 M.U.S.T. MINI POLYAXIAL SCREW CANNULATED POLYAXIAL SCREW 4.0 X 12 FULL THREAD + NUT NKG MEDACTA INTERNATIONAL SA 03.75.201 2459332 07630030863790

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other