MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-09 for NUVASIVENVM5 SYSTEM NVM5MULTI manufactured by Nuvasive, Inc..
[116602451]
Product was returned and investigation was performed. A download of the logs indicate that the nvm5 was not in use at the time of the reported event. Edge cards were replaced unrelated to reported event. Unit underwent preventive maintenance and was returned back to stock.
Patient Sequence No: 1, Text Type: N, H10
[116602452]
On (b)(6) 2018 patient underwent a lumbar procedure at the s1 level. As per reporter device provided inaccurate readings and a screw breach was noted post-operatively. Patient underwent a revision procedure on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2018-00124 |
| MDR Report Key | 7767721 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-09 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2018-06-28 |
| Date Added to Maude | 2018-08-09 |
| 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 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 | NUVASIVENVM5 SYSTEM |
| Generic Name | NEUROSURGICAL NERVE LOCATOR |
| Product Code | PDQ |
| Date Received | 2018-08-09 |
| Returned To Mfg | 2018-07-12 |
| 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, INC. |
| Manufacturer Address | 7475 LUSK BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-09 |