MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-08-20 for SPINA * manufactured by North American Medical Corp.
[258626]
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.
Patient Sequence No: 1, Text Type: D, B5
[18600921]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025918 |
| MDR Report Key | 412242 |
| Date Received | 2002-08-20 |
| Date of Report | 2002-08-20 |
| Date Added to Maude | 2002-08-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPINA |
| Generic Name | SPINA |
| Product Code | ITH |
| Date Received | 2002-08-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 401273 |
| Manufacturer | NORTH AMERICAN MEDICAL CORP |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-08-20 |