MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-05-10 for NVM5 SYSTEM manufactured by Nuvasive, Inc.
[74887870]
At this time it is unknown if there was a product malfunction or which product was used at the time of the event. No product has been returned for evaluation, therefore root cause cannot be identified. Patient has alleged a permanent injury.
Patient Sequence No: 1, Text Type: N, H10
[74887871]
A report was received indicating that following surgery the patient exhibited paraplegia secondary to a hematoma that impinged on the spinal cord. Allegation was made that the neuromonitoring device contributed to the injury. Additionally, information was also received in which there was alleged failure to perform instrumented fusion and to provide adequate hemostasis; a dural tear was also reportedly sustained, as well as failure to operate on correct anatomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2017-00040 |
| MDR Report Key | 6559311 |
| Report Source | OTHER |
| Date Received | 2017-05-10 |
| Date of Event | 2015-04-25 |
| Date Mfgr Received | 2017-04-11 |
| Date Added to Maude | 2017-05-10 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. YOBANA SANCHEZ |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8589093383 |
| Manufacturer G1 | NUVASIVE, INC |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NVM5 SYSTEM |
| Generic Name | NEUROSURGICAL NERVE LOCATOR |
| Product Code | PDQ |
| Date Received | 2017-05-10 |
| Model Number | NVM5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE, INC |
| Manufacturer Address | 7475 LUSK BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-05-10 |