BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT

    MDR report key: 13693886 · Received March 8, 2022

    Report

    Report Number
    3005180920-2022-00158
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    February 8, 2022
    Report Date
    April 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKG
    UDI-DI
    07630030863158
    PMA / PMN Number
    K171369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08-MAR-2022. LOT 2024025: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2021. EXPIRATION DATE: 2026-01-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED: MUST MINI 03.75.001 MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT (K171369) LOT 2022688: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-DEC-2020. EXPIRATION DATE: 2025-11-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MUST MINI 03.75.001 MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT (K171369) LOT 2022689: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-DEC-2020. EXPIRATION DATE: 2025-11-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MUST MINI 03.75.600 MUST MINI ROD TI Ø3.5 X 80MM (STERILE) (K171369) LOT 2120405: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUN-2021. EXPIRATION DATE: 2026-05-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MUST MINI 03.75.600 MUST MINI ROD TI Ø3.5 X 80MM (STERILE) (K171369) LOT 2122213: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2021. EXPIRATION DATE: 2026-06-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    DEVICES RETURNED ON 15-MAR-2022 AND ANALYZED ON 17-MAR-2022. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER DURING THE VISUAL INSPECTION OF RETRIEVED IMPLANTS, IT WAS OBSERVED THAT THE SET SCREWS WERE STILL INTACT WITH NO SIGN OF THREADING DEFORMATION OR OTHER SIGNS OF DAMAGE. ADDITIONALLY, ALL THE RETRIEVED SET-SCREWS WERE ASSEMBLED INTO THE POLYAXIAL SCREW HEAD IN A SAWBONES MODEL AND FIXED AS PER THE STANDARD PROCEDURE FOR TESTING WITH ASSOCIATED INSTRUMENTS.THEY WERE FIXED UNDER 3NM TORQUE AND RELEASED AS PER THE REVERSE PROCEDURE. THIS STEP WAS REPEATED TWO TIMES IN ORDER TO INVESTIGATE A POSSIBLE FAILURE MODE UNDER REPEATED USAGE. THE TEST WAS SUCCESSFULLY PERFORMED WITHOUT EVIDENCE OF IMPLANTS FAILURE. THE SCREWS WORKED WELL AS PER NEW VIRGIN SCREWS.

    Description of Event or Problem · 0

    DURING A FOLLOW-UP VISIT, 1 MONTH AFTER THE PRIMARY SURGERY, IT WAS DISCOVERED THAT THE IMPLANTED RIGHT ROD WAS DISPLACED TO THE CRANIO-CAUDAL SIDE. DURING THE REVISION SURGERY, IT WAS ALSO FOUND THAT THE SET SCREWS WERE LOOSE ON THE LEFT SIDE AS WELL, SO, ALL THE SCREWS AND RODS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573261 MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT SPINE CERVICAL POLYAXIAL SCREW NKG MEDACTA INTERNATIONAL SA 03.75.001 2024025 07630030863158

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention