BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINA

    MDR report key: 412242 · Received August 20, 2002

    Report

    Report Number
    MW1025918
    Event Type
    Malfunction
    Date Received
    August 20, 2002
    Report Date
    August 20, 2002
    Manufacturer
    NORTH AMERICAN MEDICAL CORP
    Product Code
    ITH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR IS A PRACTICING ORTHOPAEDIC SURGEON. RPTR HAS RECEIVED A MAILING FROM DR OF NORTH AMERICAN MEDICAL CORP REGARDING SPINA (510K APPROVED), INDICATING HOW MUCH MONEY RPTR COULD EARN BY USING IT. THE CLAIMS INCLUDED RELIEF FROM HERNIATED DISCS. THE DEVICE SEEMS SIMILAR TO THE VAX-D, AND RPTR KNOWS THAT FDA TOOK ACTION AGAINST THEM FOR SIMILAR CLAIMS, NOT COVERED BY THE 510K APPROVAL. RPTR CAN EMAIL OR FAX A COPY OF THEIR OFFERING.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM MFR 10/09/02: THIS MEDWATCH SUBMISSION IS CLEARLY NOT A REPORT RELEVANT TO ANY "...SERIOUS ADVERSE EVENT, POTENTIAL/ACTUAL PRODUCT ERRORS AND/OR PRODUCT QUALITY PROBLEMS..." AS INTENDED BY FDA. IN FACT, MFR IS ACTUALLY UNCLEAR AS TO THE NATURE OF ANNOYANCE THE ANONYMOUS REPORTER IS COMPLAINING ABOUT; OTHER THAN PERHAPS HAVING RECEIVED A MAIL SOLICITATION FOR THE SALE OF MEDICAL EQUIPMENT. NORTH AMERICAN MEDICAL HAS U.S. DISTRIBUTORS FUNCTIONING UNDER VERY CLEAR DIRECTIVES AS TO MARKET CLAIMS. THEIR SPINA DEVICE IS CLEARLY STATED TO BE FDA COMPLIANT. DISTRIBUTORS WHO MARKET THIS DEVICE ARE ADDRESSING LICENSED MEDICAL DOCTORS. THESE DOCTORS WILL ALSO BE REFERRED TO INDEPENDENT STUDIES CITING CO'S EQUIPMENT AS BENEFICIAL IN A TREATMENT PROTOCOL FOR THE MANAGEMENT OF BACK PAIN STEMMING FROM A NUMBER OF UNDERLYING DIAGNOSES. DISTRIBUTORS ARE NOT RESTRICTED FROM CITING EQUIPMENT COSTS OR MEDICAL PRACTICE COST/REVENUE PROJECTIONS PROVIDED THEY FALL UNDER THE APPROPRIATE FTC GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINA SPINA ITH NORTH AMERICAN MEDICAL CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *