BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUST MINI ROD TI 3.5 X 80MM (STERILE)

    MDR report key: 12159037 · Received July 13, 2021

    Report

    Report Number
    3005180920-2021-00589
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    June 22, 2021
    Report Date
    August 3, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKG
    UDI-DI
    07630030864988
    PMA / PMN Number
    K171369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICES RETURNED ON 21-JULY-2021 AD ANALYZED. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. DURING THE VISUAL INSPECTION ON RETRIEVED SET-SCREWS COMPONENT, IT WAS OBSERVED THAT THE COMPONENTS WERE STILL IN GOOD CONDITION WITH NO SIGN OF DEFORMATION AND/OR FAILURE. ADDITIONALLY, A TEST WAS PERFORMED TO INVESTIGATE ABOUT THE POSSIBLE ROOT CAUSE AND VERIFY THE ABILITY OF THE SET-SCREWS TO FULLY SECURE THE OVERALL SCREWS-ROD CONSTRUCT. IN CONCLUSION, WE HYPOSTHESIZE THAT THE ROOT CAUSE OF THIS COMPLAINT IS DUE TO NOT PERFORMING THE FINAL TIGHETENING IN THE PROPER WAY, BY USING THE ASSOCIATED PRE-SET TORQUE LIMITER SCREWDRIVER AS GIVEN IN THE RELATED SURGITAL TECHNIQUE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23.06.2021: LOT 2120973: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2021. EXPIRATION DATE: 2026-03-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 23.06.2021: MUST MINI 03.75.600 MUST MINI ROD TI Ø3.5 X 80MM (STERILE) (K171369) LOT. 1922070 LOT 1922070: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-07-2019. EXPIRATION DATE: 2024-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT. MUST MINI 03.75.002 MUST MINI POLYAXIAL SCREW 3.5 X 14 FULL THREAD + NUT (K171369) LOT. 2022678 LOT 2022678: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-10-2020. EXPIRATION DATE: 2025-10-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 3 SIMILAR REPORTED EVENTS (ALL IMPLANTS REPORTED IN THIS COMPLAINT). MUST MINI 03.75.002 MUST MINI POLYAXIAL SCREW 3.5 X 14 FULL THREAD + NUT (K171369) LOT. 2022677 LOT 2022677: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-11-2020. EXPIRATION DATE: 2025-10-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT (REPORTED IN THIS COMPLAINT). MUST MINI 03.75.002 MUST MINI POLYAXIAL SCREW 3.5 X 14 FULL THREAD + NUT (K171369) LOT. 2022255 LOT 2022255: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-10-2020. EXPIRATION DATE: 2025-09-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT. MUST MINI 03.75.002 MUST MINI POLYAXIAL SCREW 3.5 X 14 FULL THREAD + NUT (K171369) LOT. 2021938 LOT 2021938: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-09-2020. EXPIRATION DATE: 2025-09-060. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    C3-C6 FIXATION, SURGERY PERFORMED ON JUNE 16. ON THE NEXT DAY THE SURGEON TOOK THE CT IMAGE AND CONFIRMED THE RODS DISENGAGEMENT FROM THE PEDICLE SCREWS. THE SURGEON CONFIRMED 2 SET SCREWS ON THE C4 COMPLETELY DISENGAGED AND REMAINED 6 SET SCREWS LOOSENED. NO CROSS CONNECTOR USED AT THE PRIMARY SURGERY. ALL IMPLANTS WERE REVISED. THE INSTRUMENTS USED DID NOT SHOW ANY PROBLEM DURING OTHER SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060598 MUST MINI ROD TI 3.5 X 80MM (STERILE) SPINE ROD NKG MEDACTA INTERNATIONAL SA 03.75.600 2120973 07630030864988

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention