MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-19 for NUVASIVE manufactured by .
[17935487]
Use of off label devices for multi-level posterior cervical spine laminectomy fusion. Also very good possibility that off label biologies were used as grafting material. I developed h-pylori about 14 months after surgery. Also about (2) years after surgery. I was diagnosed with diverticulosis and within the last year esophagitis. I have difficulty with bowel movements. I have difficulty swallowing and digesting food.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043204 |
| MDR Report Key | 4867512 |
| Date Received | 2015-06-19 |
| Date of Event | 2010-11-10 |
| Date Added to Maude | 2015-06-26 |
| 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 | 0 |
| 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 |
| Brand Name | NUVASIVE |
| Generic Name | NUVASIVE |
| Product Code | JDN |
| Date Received | 2015-06-19 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-06-19 |