MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-16 for SPINEMED TABLE - FDA 510(K) K051013 manufactured by Cert Health Sciences, Llc.
[622824]
I am a chiropractor and purchased a spinemed table in 2006. This table is marketed to be an alternative to having back surgery for those individuals suffering from herniated discs, spinal stenosis, facet syndrome, and other degenerative spinal conditions. After having approx 15 people on the table and getting a moderately successful response from only one pt, i was concerned and called the co to ask if they would send a tech to my office to determine if i was doing something wrong or if the table was defective. The co's solution was to have me go to another individual's office to watch them set up a pt and do the procedure. I find this solution to the problem disturbing and useless. I have since spoken with other spinemed table owners and have found that my experience with the table is not uncommon. More often than not most practitioners that i spoke to are not satisfied with the pt response to being on the table. Very few people are getting better.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003064 |
| MDR Report Key | 882038 |
| Date Received | 2007-07-16 |
| Date of Report | 2007-07-15 |
| Date Added to Maude | 2007-07-24 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SPINEMED TABLE - FDA 510(K) K051013 |
| Product Code | ITH |
| Date Received | 2007-07-16 |
| Operator | HEALTH PROFESSIONAL |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 861750 |
| Manufacturer | CERT HEALTH SCIENCES, LLC |
| Manufacturer Address | 7036 GOLDEN RING RD BALTIMORE MD 21237 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-16 |