BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT

    MDR report key: 7402533 · Received April 6, 2018

    Report

    Report Number
    3005180920-2018-00213
    Event Type
    Injury
    Date Received
    April 6, 2018
    Date of Event
    March 9, 2018
    Report Date
    April 6, 2018
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOTS AND QUANTITY OF SCREW USED DURING PRIMARY SURGERY ARE : REFERENCE 03.75.001 LOT 1720772 QUANTITY 1; REFERENCE 03.75.001 LOT 1720838 QUANTITY 5; REFERENCE 03.75.006 LOT 1720777 QUANTITY 3; REFERENCE 03.75.007 LOT 1720778 QUANTITY 3; REFERENCE 03.75.007 LOT 1720844 QUANTITY 2; REFERENCE 03.75.008 LOT 1720779 QUANTITY 4. WE DO NOT KNOW WHICH ARE THE PIECES THAT BROKE OFF DURING SURGERY, FOR THIS REASON THE DOCUMENT REVIEW HAS BEEN PERFORMED ON ALL THE POSSIBLE LOTS. BATCH REVIEW PERFORMED ON 04 APRIL 2018: MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT LOT REFERENCE 03.75.001 (K171369); LOT 1720772: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 35 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. SET SCREW LOT 1720176: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 JUNE 2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT REFERENCE 03.75.001 (K171369); LOT 1720838: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JANUARY 2018. EXPIRATION DATE: 2022-12-14; 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. SET SCREW LOT 1720439: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 NOVEMBER 2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. MUST MINI POLYAXIAL SCREW 3.5 X 22 FULL THREAD + NUT REFERENCE 03.75.006 (K171369); LOT 1720777: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 OCTOBER 2017. EXPIRATION DATE: 20.09.2022; 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. SET SCREW LOT 1720176: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 SEPTEMBER 2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. MUST MINI POLYAXIAL SCREW 3.5 X 24 FULL THREAD + NUT REFERENCE 03.75.007 (K171369); LOT 1720778: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 OCTOBER 2017. EXPIRATION DATE: 2022-09-18; 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. SET SCREW LOT 1720174: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 SEPTEMBER 2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. MUST MINI POLYAXIAL SCREW 3.5 X 24 FULL THREAD + NUT REFERENCE 03.75.007 (K171369); LOT 1720844: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JANUARY 2018 2017. EXPIRATION DATE: 2022-12-14; 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. SET SCREW LOT 1720179: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. MUST MINI POLYAXIAL SCREW 3.5 X 26 FULL THREAD + NUT REFERENCE 03.75.008 (K171369); LOT 1720779: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-24; 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. SET SCREW LOT 1720176: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 JUNE 2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. CLINICAL EVALUATION PERFORMED ON 23 MARCH 2018 BY MEDICAL AFFAIRS: WHILE INSERTING THE SET SCREW IN THE PEDICLE SCREW TULIP, THE THREAD OF A SET SCREW BROKE. THE SCREW WAS REPLACED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE IS NO CLINICAL REASON OF THIS EVENT AND NO CONSEQUENCE SHOULD BE EXPECTED FOR THE PATIENT.

    Description of Event or Problem · 1

    THE SURGEON HAD DIFFICULTY TO TIGHTEN THREE SET SCREWS INTO THE PEDICLE SCREW TULIPS. AFTER MANY ATTEMPTS, THE THREAD OF THE THREE SET SCREWS BROKE (LOTS THAT BROKE OFF ARE UNKNOWN, 18 SCREWS WERE USED). THREE NEW SET SCREWS WERE USED IN ORDER TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245924 MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT POLYAXIAL SCREW NKG MEDACTA INTERNATIONAL SA 1720772 07630030863158

    Patients

    Seq Age Sex Outcome Treatment
    1 Other