BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW 03.58.264 MUST MC SCREW Ø7X40 CANNULATED

    MDR report key: 19097071 · Received April 12, 2024

    Report

    Report Number
    3005180920-2024-00218
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    March 14, 2024
    Report Date
    May 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971293762
    PMA / PMN Number
    K210427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER ON PEDICLE SCREW 03.58.264 MUST MC SCREW Ø7X40 CANNULATED LOT. 2321451. PEDICLE SCREW FRACTURED UNDER THE NECK, IN A WAY COMPATIBLE WITH MATERIAL FATIGUE. THIS BREAKAGE IS COMPATIBLE WITH THE ROOT CAUSES IDENTIFIED IN THE CLINICAL EVALUATION. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER ON MECTALIF POSTERIOR (TI PEEK) 03.27.007 POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X9 L5° LOT. 2023860 THE MECTALIF POSTERIOR 03.27.007, LOT NO 2023860, APPEARS ACCORDING TO THE SPECIFICATION (NO BREAKAGES OR DEFORMATION) EXCEPT FOR SIGNS OF WEAR ON THE POSTERIOR SIDE OF THE CAGE COMPATIBLE WITH THE INSERTION/REMOVAL OF THE DEVICE. ACCORDING TO THE DESCRIPTION OF THE COMPLAINT THE IMPLANT MIGRATED AND IT WAS, THEN, REMOVED. THE MIGRATION OF THE IMPLANT IS COMPATIBLE WITH THE ROOT CAUSE IDENTIFIED IN THE CLINICAL EVALUATION. THE CLINICAL EVALUATION, ALREADY REPORTED TO YOU IN THE INITIAL MDR 2024-00218 IS THE FOLLOWING: 9 MONTHS FOLLOWING PRIMARY FUSION SURGERY AT THE L4-S1 LEVEL UTILIZING PEDICLE SCREWS, RODS, TLIF (AT L4-L5) AND PLIF (AT L5-S), A SCREW BREAKAGE (S1 LEFT SCREW) WAS IDENTIFIED DURING A ROUTINE X-RAY EXAMINATION. NO DETAILS REGARDING THE PATINET'S CLINICAL CONDITION WERE REPORTED. ANALYSIS OF THE AVAILABLE X-RAY CONFIRMS THE BREAKAGE OF THE LEFT S1 SCREW, ALONG WITH THE BACKING OUT AND SUBSIDENCE OF BOTH PLIF CAGES AT L5-S1 LEVEL. DURING THE SURGERY, THE RIGHT S1 SCREW WAS FOUND LOOSENED. PEDICLE SCREWS CAN SUFFER FATIGUE FRACTURES WHEN BONE FUSION DID NOT TAKE PLACE, SUBJECTING THE DEVICE TO ONGOING CONTINUOUS STRESS. IDENTIFYING THE CAUSE OF FUSION FAILURE CAN BE CHALLENGING, AS IT MAY BE INFLUENCED BY VARIOUS FACTORS SUCH AS THE BIOLOGICAL CHARACTERISTIC OF THE PATIENT OR THE IMPROPER LOAD DISTRUBUTION: IN THIS CASE, THE SIGNIFICANTLY REDUCED LUMBAR LORDOSIS MAY HAVE PLAYED A ROLE. EVEN THE MIGRATION OF THE CAGES MAY HAVE BEEN INFLUENCED BY THE LACK OF BONE FUSION, ALONG WITH OTHER POSSIBLE FACTORS SUCH AS INADEQUATE PRIMARY STABILITY OFTEN RELATED TO THE INITIAL POSITIONING, PREPARATION OF THE ENDPATES, POSTERIOR COMPRESSION, UNDERSIZING, ETC. A REVISION SURGERY WAS CONDUCTED REVISING THE S1 SCREWS, EXTENDING THE CONSTRUCT TO S2 AND REVISING THE CAGES AT L5-S1. WITH THE ELEMENTS AT DISPOSAL IT IS DIFFICULT TO SUSPECT A DEFECTIVE OR FAULTY DEVICE. INFORMATION REPORTED IN THIS FOLLOW UP: - VISUAL INSPECTION OF THE TWO RECEIVED DEVICES. - DATA RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 26 MARCH 2024. LOT 2321451: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MARCH-2023. EXPIRATION DATE: 2028-MARCH-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: 9 MONTHS FOLLOWING PRIMARY FUSION SURGERY AT THE L4-S1 LEVEL UTILIZING PEDICLE SCREWS, RODS, TLIF (AT L4-L5) AND PLIF (AT L5-S), A SCREW BREAKAGE (S1 LEFT SCREW) WAS IDENTIFIED DURING A ROUTINE X-RAY EXAMINATION. NO DETAILS REGARDING THE PATINET'S CLINICAL CONDITION WERE REPORTED. ANALYSIS OF THE AVAILABLE X-RAY CONFIRMS THE BREAKAGE OF THE LEFT S1 SCREW, ALONG WITH THE BACKING OUT AND SUBSIDENCE OF BOTH PLIF CAGES AT L5-S1 LEVEL. DURING THE SURGERY, THE RIGHT S1 SCREW WAS FOUND LOOSENED. PEDICLE SCREWS CAN SUFFER FATIGUE FRACTURES WHEN BONE FUSION DID NOT TAKE PLACE, SUBJECTING THE DEVICE TO ONGOING CONTINUOUS STRESS. IDENTIFYING THE CAUSE OF FUSION FAILURE CAN BE CHALLENGING, AS IT MAY BE INFLUENCED BY VARIOUS FACTORS SUCH AS THE BIOLOGICAL CHARACTERISTIC OF THE PATIENT OR THE IMPROPER LOAD DISTRUBUTION: IN THIS CASE, THE SIGNIFICANTLY REDUCED LUMBAR LORDOSIS MAY HAVE PLAYED A ROLE. EVEN THE MIGRATION OF THE CAGES MAY HAVE BEEN INFLUENCED BY THE LACK OF BONE FUSION, ALONG WITH OTHER POSSIBLE FACTORS SUCH AS INADEQUATE PRIMARY STABILITY OFTEN RELATED TO THE INITIAL POSITIONING, PREPARATION OF THE ENDPATES, POSTERIOR COMPRESSION, UNDERSIZING, ETC. A REVISION SURGERY WAS CONDUCTED REVISING THE S1 SCREWS, EXTENDING THE CONSTRUCT TO S2 AND REVISING THE CAGES AT L5-S1. WITH THE ELEMENTS AT DISPOSAL IT IS DIFFICULT TO SUSPECT A DEFECTIVE OR FAULTY DEVICE. OTHER DEVICES INVOLVED: MECTALIF POSTERIOR (TI PEEK) 03.27.007 POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X9 L5° (K133192) LOT 2023860: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MARCH-2021. EXPIRATION DATE: 2026-FEB-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.58.264 MUST MC SCREW Ø7X40 CANNULATED (K210427) LOT 2228101: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2022. EXPIRATION DATE: 2026-FEB-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    PRIMARY SURGERY WAS PERFORMED AT L4-S1.TLIF SURGERY. OPEN PROCEDURE. REVISION SURGERY WAS PERFORMED ABOUT 9 MONTHS AFTER THE PRIMARY SURGERY AT L4-S2AI DUE TO SCREW BREAKAGE AT S1 LEFT (LOT 2321451), SCREW LOOSENING AT S1 RIGHT (LOT 2228101), AND THE BACK-OUT AND SINKING OF THE CAGE AT L5-S1. THE SURGEON REPLACED THE PEDICLE SCREW AT S1 LEFT (DIAMETER 7MM) WITH A SCREW OF DIAMETER 8MM, THE SCREW AT S1 RIGHT (DIAMETER 7MM) WITH A SCREW OF 10MM DIAMETER, AND THE CAGE WITH A COMPETITOR'S CAGE (HEIGHT 10 MM). PATIENT WITH PSEUDARTHROSIS. BONE QUALITY NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769934 PEDICLE SCREW 03.58.264 MUST MC SCREW Ø7X40 CANNULATED SPINE MUST MC SCREW NKB MEDACTA INTERNATIONAL SA 2321451 07630971293762

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention