BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC IMPLANT

    MDR report key: 21750264 · Received April 2, 2025

    Report

    Report Number
    0000001-2025-00001
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    June 21, 2015
    Report Date
    April 2, 2025
    Manufacturer
    AUXEIN MEDICAL PRIVATE LIMITED
    Product Code
    MBI
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT MAY BE BASED ON INFORMATION WHICH AUXEIN MEDICAL PRIVATE LIMITED HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA AND AUXEIN MEDICAL PRIVATE LIMITED THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THIS REPORT IS BASED ON THE COMPLAINANT'S PERCEPTION OF ILLEGAL INTRODUCTION OF OSTEOSYNTHESIS IMPLANTS INTO THE EUROPEAN UNION IN THE YEAR 2015 AND CLAIMING THE FAILURE OF IMPLANT. IN YEAR 2021, A REPORT RELATED TO THIS COMPLAINT HAS BEEN SENT TO EUROPEAN NOTIFIED BODY, DNV NORWAY WHICH WAS INVESTIGATED BY THEM AND THE COMPLAINT WAS QUASHED AND IT BECAME NULL AND VOID. THE COMPLAINANT MENTIONED THE ORGANIZATION'S NAMES "WHITE ORTHOPAEDICS" AND "HOFFMAN ORTHOPAEDICS" IN HIS COMPLAINT, AUXEIN MEDICAL PRIVATE LIMITED DO NOT HAVE ANY DISTRIBUTION OR OTHER TYPE OF AGREEMENT WITH THEM AND ALSO NEVER WORKED WITH THESE ORGANIZATIONS IN THE PAST. THE FULL UDI AND THE FAILED SAMPLE ARE CURRENTLY NOT AVAILABLE TO AUXEIN MEDICAL PRIVATE LIMITED THIS REPORT MAY BE BASED ON INFORMATION WHICH AUXEIN MEDICAL PRIVATE LIMITED HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA AND AUXEIN MEDICAL PRIVATE LIMITED THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THIS REPORT IS BASED ON THE COMPLAINANT'S PERCEPTION OF ILLEGAL INTRODUCTION OF OSTEOSYNTHESIS IMPLANTS INTO THE EUROPEAN UNION IN THE YEAR 2015 AND CLAIMING THE FAILURE OF IMPLANT. IN YEAR 2021, A REPORT RELATED TO THIS COMPLAINT HAS BEEN SENT TO EUROPEAN NOTIFIED BODY, DNV NORWAY WHICH WAS INVESTIGATED BY THEM AND THE COMPLAINT WAS QUASHED AND IT BECAME NULL AND VOID. THE COMPLAINANT MENTIONED THE ORGANIZATION'S NAMES "WHITE ORTHOPAEDICS" AND "HOFFMAN ORTHOPAEDICS" IN HIS COMPLAINT, AUXEIN MEDICAL PRIVATE LIMITED DO NOT HAVE ANY DISTRIBUTION OR OTHER TYPE OF AGREEMENT WITH THEM AND ALSO NEVER WORKED WITH THESE ORGANIZATIONS IN THE PAST. THE FULL UDI AND THE FAILED SAMPLE ARE CURRENTLY NOT AVAILABLE TO AUXEIN MEDICAL PRIVATE LIMITED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. . IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    NOTIFICATION MY NAME IS (B)(6). OVER TIME, I HAVE VISITED THE UNITED STATES FOUR TIMES, WHICH HAS LED ME TO DEVELOP AN ATTACHMENT TO THE AMERICAN PEOPLE AND A DEEP RESPECT FOR YOUR COUNTRY. FURTHERMORE, I HAVE TWO SONS WHO LIVE IN LONDON. MY ELDEST SON, (B)(6), IS A COUNCILOR IN (B)(6) FOR (B)(6) AND ALSO SERVES AS THE DIRECTOR OF (B)(6) IN (B)(6), WHICH IS HEADQUARTERED IN (B)(6) HE WAS, FOR APPROXIMATELY 10 YEARS, AN ADVISOR IN SEVERAL MINISTRIES OF THE UNITED KINGDOM GOVERNMENT. I PRESENT THE PETITION I HAVE SUBMITTED TO THE EUROPEAN PARLIAMENT AGAINST ROMANIA, NORWAY, AND ITALY. THE PETITION HAS BEEN ACCEPTED FOR ANALYSIS AND HAS BEEN ASSIGNED REGISTRATION NUMBER (B)(4). THE SUBJECT OF THE PETITION IS: "THE ILLEGAL INTRODUCTION OF OSTEOSYNTHESIS IMPLANTS INTO THE EUROPEAN UNION." UPON READING THE PETITION, YOU WILL NOTE REASONABLE SUSPICIONS WARRANTING INVESTIGATION BY SPECIALIZED AMERICAN AUTHORITIES INTO THE ACTIVITIES OF THE COMPANY WHITE ORTHOPEDICS. BASED ON MY INVESTIGATIONS, THE ACTIVITY OF WHITE ORTHOPEDICS IN THE USA IS SIMILAR TO THAT OF HOFFMAN ORTHOPAEDICS IN EUROPE, A COMPANY THAT WAS IMMEDIATELY DISSOLVED BY THE SPECIFIC AUTHORITY MHRA IN THE UNITED KINGDOM FOLLOWING A FORMAL COMPLAINT. FURTHERMORE, I BELIEVE THE LEGALITY OF THE ACTIVITIES OF (B)(6), ON U.S. TERRITORY SHOULD BE EXAMINED. THERE IS INFORMATION SUGGESTING THAT HE MAY HAVE LIVED IN THE USA. I AM BRINGING THIS INFORMATION TO YOUR ATTENTION TO ENSURE THAT NO OTHER PATIENT, REGARDLESS OF NATIONALITY, ENDURES THE SUFFERING I HAVE GONE THROUGH IS LEFT WITH A LIFELONG DISABILITY. I HAVE ONE REQUEST OF YOU: IF YOUR INVESTIGATIONS REVEAL ACTIVITIES CONTRARY TO THE LEGAL FRAMEWORK, PLEASE INFORM MHRA FROM UK, THE EUROPEAN PARLIAMENT AND THE EUROPEAN COMMISSION THROUGH THE SPECIALIZED DEPARTMENT FOR MEDICAL DEVICES, DG-SANTE, FILE (B)(4), AND KINDLY SEND ME A SIMPLE EMAIL. THANK YOU! THIS E-MAIL WAS SENT TO US EMBASSY IN BUCHAREST ALSO! PLEASE SENT ME AN E-MAIL ADDRESS TO SENT YOU THE PETITION, WHERE YOU CAN FIND ALL THE DETAILS AND PROVES!!! IN THE PETITION YOU WILL FIND THE TECHNICAL EXPERTISE ORDERED BY ROMANIAN PROSECUTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2324765 ORTHOPEDIC IMPLANT FASTNER,FIXATATION MBI AUXEIN MEDICAL PRIVATE LIMITED 7H TI-743.107L 10941

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Disability