BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM

    MDR report key: 16459487 · Received March 1, 2023

    Report

    Report Number
    3005180920-2023-00120
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    January 30, 2023
    Report Date
    March 1, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030857584
    PMA / PMN Number
    K141988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 FEBRUARY 2023 LOT 1820933: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-SEP-2018. EXPIRATION DATE: 2023-08-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PRELIMINARY INVESTIGATION. THE CASE WAS DISCUSSED BY THE R&D SPINE DIRECTOR WITH THE SURGEON AND A SUSPECTED PSEUDOARTHROSIS WITH THE ABSENCE OF FUSION IS, WITH HIGH PROBABILITY, THE REASON FOR THE BREAKAGE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. ABOUT 3.5 YEARS AFTER PRIMARY LUMBAR STABILIZATION SURGERY, AN EXTENSION OF THE CONSTRUCT BECOMES NECESSARY, MOST PROBABLY TO INCLUDE ADJACENT LEVELS, DUE TO DISEASE PROGRESSION. DURING THE EXTENSION SURGERY, ONE OF THE ORIGINAL SCREWS IS FOUND BROKEN. THIS MAY HAPPEN, IN VERY RARE CASES, WHEN THE PERMANENCE IN SITU OF THE SCREWS IS PROLONGED FOR SEVERAL YEARS AND THERE MAY HAVE BEEN DELAYED FUSION. IN THESE CASES, FATIGUE FRACTURE CAN OCCUR. THIS IS A POSSIBLE LONG-TERM ADVERSE EVENT FOLLOWING SPINAL FUSION SURGERY, DESCRIBED IN LITERATURE AND IN THE INSTRUCTIONS FOR USE LEAFLET. IT DOES NOT NECESSARILY IMPLY A DEFECT IN THE IMPLANT. NO CLINICAL CONSEQUENCE FOR THE PATIENT IS TO BE EXPECTED AT THIS STAGE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DURING A POST-OP APPOINTMENT. THE SURGEON TOOK X-RAYS AND DECIDED TO SCHEDULE AN ADDITIONAL SURGERY AT ABOUT 3 YEARS 7 MONTHS AFTER THE PRIMARY TO EXTEND THE PATIENT'S CONSTRUCT. DURING THE ADDITIONAL SURGERY, IT WAS OBSERVED THAT THE L5 MUST MC SCREW WAS BROKEN (TULIP HEAD CAME OFF). THE SURGEON COULD NOT REMOVE THE REST OF THE SCREW AND PROCEEDED TO EXTEND THE PATIENTS CONSTRUCT. THERE WAS NO DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142998 PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM SPINE PEDICLE SCREW CANNULATED NKB MEDACTA INTERNATIONAL SA 03.52.323 1820933 07630030857584

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention