BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUST LT 03.57.024 MUST LT 15MM SHORT - PEDICLE SCREW 6X40 CANN

    MDR report key: 12438319 · Received September 8, 2021

    Report

    Report Number
    3005180920-2021-00712
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    August 6, 2021
    Report Date
    October 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971278387
    PMA / PMN Number
    K203482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2021: LOT 2024304: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-APR-2021. EXPIRATION DATE: 2026-03-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 12 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 1,5 MONTHS AFTER 1-LEVEL PRIMARY LUMBAR STABILIZATION SURGERY, ONE OF THE RODS DISENGAGED FROM THE CONNECTOR. THIS MAY HAVE HAPPENED AFTER A QUASI-TRAUMATIC EVENT OR IN CASE THE ROD SELECTED ENDED UP BEING TOO SHORT, WHICH IS UNLIKELY GIVEN THE SURGEON'S COMMENT ON THE MATTER: IN ANY CASE, THIS CANNOT BE JUDGED FROM THE XRAYS. IF INSUFFICIENT HOLDING FORCE ALLOWED THE ROD TO SLIP, TECHNICAL ANALYSIS OF THE EXPLANTS MAY BE ABLE TO TELL IF THERE WAS A TOLERANCE PROBLEM. FROM THE CLINICAL POINT OF VIEW, THE ANALYSIS IS UNLIKELY TO GIVE FURTHER LEADS TO EXPLAIN THE EVENT. VISUAL INSPECTION PERFORMED BY R&D MANAGER: PICTURES AND ADDITIONAL INFORMATION HAVE BEEN TAKEN IN CONSIDERATION. PRIMARY SURGERY WAS PERFORMED IN JUNE. AFTER ONE MONTH BY A CT SCAN THE SURGEON DETECTED A ROD DISENGAGEMENT. ANALYZING THE CT SCAN DONE AFTER THE PRIMARY SURGERY AND ANALYZING THE RODS REMOVED AND RECEIVED WE COULD ASSUMPTION THAT: ROD A (LOT NUMBER 1621533) THE CAUSE OF THE DISENGAGEMENT COULD BE THAT THE ROD HAS BEEN INSERTED TO MUCH IN THE CRANIAL IMPLANT SO THAT THE SETSCREW WORKS ON THE HEXAGON AND NOT ON THE CYLINDRICAL SURFACE. AN ADDITIONAL CAUSE COULD BE THE NOT CORRECT FINAL TIGHTENING. ROD B (LOT NUMBER 20220231) THE CAUSE OF THE REPLACEMENT OF THE ROD COULD BE THE NOT CORRECT LENGTH OF THE ROD INSERTED IN THE PRIMARY SURGERY. AS DEMONSTRATED IN THE CT DONE AFTER THE FIRST SURGERY THE ROD IS NOT COMPLETELY INSERTED IN THE CAUDAL IMPLANT AND THE SETSCREW WORKS IN NOT CORRECT POSITION. WITH THE MR312-21 THE ROD MEASURING DEVICE (03.52.10.0735) HAS BEEN IMPROVED INCREASING THE READABILITY OF THE PLATE AND MODIFYING THE GEOMETRY OF THE INDICATOR. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2021. PEDICLE SCREW 03.52.425 ENH. BENT ROD TI 5.5X45MM (K141988) LOT 1621533: 80 ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2018. EXPIRATION DATE: 2023-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 70 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. BATCH REVIEW PERFORMED ON 07 OCTOBER 2021 PEDICLE SCREW 03.52.426 ENH. BENT ROD TI 5.5X50MM (K141988) LOT 2022023: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2020. EXPIRATION DATE: 2025-10-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 34 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    PRIMARY SURGERY WAS PERFORMED ON (B)(6). THERE WAS NO ABNORMALITY IN THE EXAMINATION ONE WEEK AFTER THE PRIMARY SURGERY. THE PATIENT HAD A CT SCAN ABOUT ONE MONTH AFTER THE PRIMARY SURGERY AND THE SURGEON NOTICED RODS DISENGAGEMENT. THE SURGEON REVISED ROD AND L4 SCREW ON THE (B)(6) 2021. AT THE TIME OF PRIMARY SURGERY, THE SURGEON MEASURED THE ROD LENGTH WITH ROD MEASURING DEVICE REF 03.52.10.0735, THE ROD LENGTH WAS ENOUGH. THE FINAL TIGHTENING WAS DONE CORRECTLY DURING PRIMARY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2021: LOT 2024304: 70 ITEMS MANUFACTURED AND RELEASED ON 06-APR-2021. EXPIRATION DATE: 2026-03-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 12 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 1,5 MONTHS AFTER 1-LEVEL PRIMARY LUMBAR STABILIZATION SURGERY, ONE OF THE RODS DISENGAGED FROM THE CONNECTOR. THIS MAY HAVE HAPPENED AFTER A QUASI-TRAUMATIC EVENT OR IN CASE THE ROD SELECTED ENDED UP BEING TOO SHORT, WHICH IS UNLIKELY GIVEN THE SURGEON'S COMMENT ON THE MATTER: IN ANY CASE, THIS CANNOT BE JUDGED FROM THE XRAYS. IF INSUFFICIENT HOLDING FORCE ALLOWED THE ROD TO SLIP, TECHNICAL ANALYSIS OF THE EXPLANTS MAY BE ABLE TO TELL IF THERE WAS A TOLERANCE PROBLEM. FROM THE CLINICAL POINT OF VIEW, THE ANALYSIS IS UNLIKELY TO GIVE FURTHER LEADS TO EXPLAIN THE EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2021. PEDICLE SCREW 03.52.425 ENH. BENT ROD TI 5.5X45MM (K141988) LOT 1621533: 80 ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2018. EXPIRATION DATE: 2023-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 70 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    PRIMARY SURGERY WAS PERFORMED ON (B)(6). THERE WAS NO ABNORMALITY IN THE EXAMINATION ONE WEEK AFTER THE PRIMARY SURGERY. THE PATIENT HAD A CT SCAN ABOUT ONE MONTH AFTER THE PRIMARY SURGERY AND THE SURGEON NOTICED RODS DISENGAGEMENT. THE SURGEON REVISED ROD AND L4 SCREW ON THE (B)(6) 2021. AT THE TIME OF PRIMARY SURGERY, THE SURGEON MEASURED THE ROD LENGTH WITH ROD MEASURING DEVICE REF (B)(4), THE ROD LENGTH WAS ENOUGH. THE FINAL TIGHTENING WAS DONE CORRECTLY DURING PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338185 MUST LT 03.57.024 MUST LT 15MM SHORT - PEDICLE SCREW 6X40 CANN SPINE PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 03.57.024 2024304 07630971278387

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention