MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04,07 report with the FDA on 2012-03-28 for NUVASIVE NVM5 SYSTEM NA manufactured by Nuvasive, Inc..
[2574273]
It was reported that on (b)(6) 2011 the patient underwent a surgery for an l4-l5 disc herniation via tlif approach to perform discectomy and fusion that the surgeon cut a nerve root that resulted in permanent nerve damage. No other patient info is known.
Patient Sequence No: 1, Text Type: D, B5
[9949053]
(b)(4). The device has been unavailable for evaluation. No root cause(s) or contributing factors related to the injury have been established.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031966-2012-00009 |
| MDR Report Key | 2518034 |
| Report Source | 00,04,07 |
| Date Received | 2012-03-28 |
| Date of Report | 2012-03-27 |
| Date of Event | 2011-01-26 |
| Report Date | 2012-03-27 |
| Date Mfgr Received | 2012-02-27 |
| Device Manufacturer Date | 2010-01-29 |
| Date Added to Maude | 2012-04-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAUL HOLBROOK |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8583205285 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUVASIVE NVM5 SYSTEM |
| Generic Name | ELECTROMYOGRAPHY (EMG) MONITOR / STIMULATOR |
| Product Code | BXM |
| Date Received | 2012-03-28 |
| Model Number | NVM5 |
| Catalog Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 27 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-28 |