SPINA
Received Aug 20, 2002
Report MW1025918 · MDR key 412242
Device
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
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
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.