BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUST MINI MUST MINI POLYAXIAL SCREW 3.5 X 24 FULL THREAD + NUT

    MDR report key: 10269860 · Received July 14, 2020

    Report

    Report Number
    3005180920-2020-00424
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    June 19, 2020
    Report Date
    July 14, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKG
    UDI-DI
    07630030863219
    PMA / PMN Number
    K171369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 JULY 2020: LOT 1822191: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2019. EXPIRATION DATE: 2024-02-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOVLED IN THE EVENT, BATCH REVIEW PERFORMED ON 13 JULY 2020: MUST MINI 03.75.111 MUST MINI POLYAXIAL SCREW 4.0 X 32 FULL THREAD + NUT (K171369), LOT. 1822701. LOT 1822701: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2018. EXPIRATION DATE: 2023-11-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MUST MINI 03.75.311 MUST MINI POLYAXIAL SCREW 4.5 X 32 FULL THREAD + NUT (K171369), LOT. 1822182. LOT 1822182: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2018. EXPIRATION DATE: 2023-10-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A POST-OP VISIT, IT WAS OBSERVED THAT ONE SET SCREW WAS DISENGAGED FROM THE MUST MINI SCREW AND TWO OTHER SET SCREWS WERE LOOSE. THE SURGEON REVISED THE POLY-AXIAL SCREWS AT C7 AND T2 WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE SET SCREWS IN ALL REMAINING MEDACTA POLY-AXIAL SCREWS WITH MEDACTA SET SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. 2 SET SCREWS LOOSE AND 1 UNSCREWED. THE TWO PEDICLE SCREWS WERE REVISED DUE TO THE FACT THAT THE SURGEON WANTED A MORE ROBUST CONSTRUCT AND HE IMPLANTED 2 PEDICLE SCREWS AND A 3.5MM - 6.0MM TRANSITION ROD. THE SURGEON REMOVED THE SET SCREWS BECAUSE HE HAD TO REMOVE THE ROD SO IT WAS NECESSARY TO REMOVE SCREWS. THE 3NM SCREWDRIVER HAS BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736148 MUST MINI MUST MINI POLYAXIAL SCREW 3.5 X 24 FULL THREAD + NUT MUST MINI SCREW NKG MEDACTA INTERNATIONAL SA 03.75.007 1822191 07630030863219

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention