BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTRESS PEDICULAR FIXATION

    MDR report key: 19650344 · Received July 1, 2024

    Report

    Report Number
    3006846753-2024-00001
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Manufacturer
    BRADSHAW MEDICAL INC.
    Product Code
    LXH
    UDI-DI
    M7406410017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTION OF THE DEVICE FOUND IT TO BE WITHIN SPECIFICATION. UNIT MEASURED 8.92-9.20 NM (SPECIFICATION RANGE 8.5-11.5 NM). NO ACTIONS WERE TAKEN. THIS IS A BELATED REPORT FOR A MEDICAL DEVICE RELATED EVENT THAT WAS REPORTED ON JUNE 16, 2016. THIS IS A BELATED REPORT FOR A MEDICAL DEVICE RELATED EVENT THAT OCCURRED ON JUNE 16, 2016. AT THE TIME, OUR COMPANY (BRADSHAW MEDICAL INC.) WAS NOT FULLY AWARE OF SPECIFIC REQUIREMENTS FOR MDR REPORTING. WE ARE SUBMITTING THIS REPORT NOW TO ENSURE COMPLETED TRANSPARENCY AND COMPLIANCE WITH FDA REGULATIONS. SINCE THIS INCIDENT, WE HAVE IMPLEMENTED IMPROVED PROCEDURES TO ENSURE TIMELY REPORTING OF ALL MDR EVEN.

    Description of Event or Problem · 0

    AN MDR REPORT WAS NOT SUBMITTED WITHIN 30 DAYS OF RECEIVING OR OTHERWISE BECOMING AWARE OF INFORMATION BELOW THAT REASONABLY SUGGESTS THAT A MARKETED DEVICE HAD MALFUNCTIONED AND REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. SPECIFICALLY, BRADSHAW MEDICAL INC. FAILED TO SUBMIT AN MDR REPORT WITHIN 30 DAYS FOR AN EVENT REPORTED TO BRADSHAW MEDICAL WHICH FORTRESS FINAL DRIVER ORTHOPEDIC SURGICAL DEVICE PART NO 64-04-01 FDA A CLASS I DEVICE WAS USED IN SPINE SURGERY WHERE SET SCREW BECAME LOOSE AND REQUIRED A REVISION SURGERY TO TIGHTEN SCREW. THIS IS A BELATED REPORT FOR A MEDICAL DEVICE RELATED EVENT THAT BRADSHAW MEDICAL INC. BECAME AWARE OF ON 16JUN2016 AND IS DOCUMENTED IN COMPANY'S COMPLAINTS (B)(4) (SAME EVENT). AT THE TIME, OUR COMPANY (BRADSHAW MEDICAL INC.) WAS NOT FULLY AWARE OF THE SPECIFIC REQUIREMENTS FOR MDR REPORTING. WE ARE SUBMITTING THIS REPORT NOW TO ENSURE COMPLETE TRANSPARENCY AND COMPLIANCE WITH FDA REGULATIONS. SINCE THIS INCIDENT, WE HAVE IMPLEMENTED PROCEDURES TO ENSURE TIMELY REPORTING OF ALL MDR EVENTS. DURING A 2017 FDA OBSERVATION, IT WAS NOTED THAT A LATE MDR WAS NECESSARY. HOWEVER, DURING FEB 2022 FDA INSPECTION, IT WAS OBSERVED THAT THE MDR WAS NOT ISSUED. THE FDA FORM 483 INDICATED THAT BRADSHAW FAILED TO REPORT THE MDR DUE TO A LACK OF RESOURCES. AT THAT TIME, WE WERE UNSURE IF IT WAS ACCEPTABLE TO SUBMIT A LATE MDR. HOWEVER, WE HAVE SINCE CONFIRMED THAT MDRS MUST BE REPORTED EVEN IF THEY ARE LATE. AS A CORRECTIVE ACTION, WE HAVE IMPLEMENTED A PROCESS TO ENSURE TIMELY MDR SUBMISSIONS IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507252 FORTRESS PEDICULAR FIXATION FINAL DRIVER LXH BRADSHAW MEDICAL INC. 64-04-01 BR14024 M7406410017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown