BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW MUST MC CROSS-CONNECTOR 19-29MM ADJUSTABLE

    MDR report key: 16332042 · Received February 9, 2023

    Report

    Report Number
    3005180920-2023-00055
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    January 12, 2023
    Report Date
    March 13, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630040728799
    PMA / PMN Number
    K193365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED ON 20 FEBRUARY 2023 BY MEDACTA SPINE R&D PROJECT MANAGER: THE IMPLANT APPEARS TO BE TORSIONALLY TWISTED. A NEW IMPLANT OF THE SAME REFERENCE HAS BEEN TAKEN OFF THE SHELF AND HAS BEEN TWISTED ON PURPOSE, USING THE COUNTERTORQUE. IT WAS NOT POSSIBLE TO REPLICATE THE DEFORMATION OF THE IMPLANT OBJECT OF THE COMPLAINT, THEREFORE A FAILURE DURING IMPLANT INSERTION AND FINAL TIGHTENING HAS TO BE EXCLUDED. A CERTAIN ROOT CAUSE CANNOT BE IDENTIFIED WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 JANUARY 2023. LOT: 2126491: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-DEC-2021. EXPIRATION DATE: 2026-NOV-16. 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. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 16 JANUARY 2023: PEDICLE SCREW 03.52.337 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X40MM (K141988) LOT: 2127340 LOT: 2127340: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JAN-2022. EXPIRATION DATE: 2026-DEC-15. 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 PERFORMED 6 MONTHS AGO (JULY 2022), L4-L5-S1 TLIF. SIX MONTHS LATER, L4-L5 PRESENTED BONY FUSION, HOWEVER, L5-S1 RESULTED IN PSEUDOARTHROSIS WITH S1 SCREW LOOSENING. THE CROSS-CONNECTOR WAS LOCATED AT L4-L5. AT THE REVISION SURGERY, THE CROSS-CONNECTOR WAS NOT STABLE ALREADY BEFORE REMOVING THE SET SCREWS. L4 AND L5 PEDICLE SCREWS WERE OK WITHOUT ANY SIGNS OF LOOSENING AND L4-L5 WAS COMPLETELY FUSED, BUT THE CROSS-CONNECTOR AT L4-L5 SHOWED LOOSENING; WHILE IN L5-S1 WAS NON-UNION AND S1 SCREWS WERE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607526 PEDICLE SCREW MUST MC CROSS-CONNECTOR 19-29MM ADJUSTABLE SPINE CROSS CONNECTOR NKB MEDACTA INTERNATIONAL SA 03.56.503 2126491 07630040728799

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention