MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-01-24 for NUVASIVENVM5 SYSTEM NVM5MULTI manufactured by Nuvasive.
[135356284]
Product was returned and investigation was performed. Latest logs saved were from october and event was reported in december. Edge cards were replaced unrelated to reported event. Power cycled unit 3 times and ran dynamic stim tests without any issues.
Patient Sequence No: 1, Text Type: N, H10
[135356365]
As per reporter device provided inaccurate readings and screw breach was noted during x-ray review. It is unknown if patient underwent a revision procedure or if screw breach was addressed intra-operative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2019-00156 |
| MDR Report Key | 8276762 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-01-24 |
| Date of Report | 2019-01-24 |
| Date Mfgr Received | 2019-01-24 |
| Device Manufacturer Date | 2017-05-26 |
| Date Added to Maude | 2019-01-24 |
| 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 | MS. YOBANA SANCHEZ |
| Manufacturer Street | 7475 LUSK BOULEVARD |
| Manufacturer City | SAN DIEGO 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8589093383 |
| Manufacturer G1 | NUVASIVE |
| Manufacturer Street | 7475 LUSK BOULEVARD |
| 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 | NUVASIVENVM5 SYSTEM |
| Generic Name | NEUROSURGICAL NERVE LOCATOR |
| Product Code | PDQ |
| Date Received | 2019-01-24 |
| Returned To Mfg | 2018-12-03 |
| Model Number | NVM5MULTI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE |
| Manufacturer Address | 7475 LUSK BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-24 |