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 2020-02-07 for NUVASIVE NVM5 SYSTEM manufactured by Nuvasive.
[183103899]
No product has been returned for investigation as no product malfunction alleged. Event was found during literature review. No root cause can be determined at this time. Literature review: potential adverse events and complications: "... As with any major surgical procedures, there are risks involved in spinal/orthopedic surgery... "
Patient Sequence No: 1, Text Type: N, H10
[183103900]
During literature review it was identified that between the dates of 12/2005 and 9/2011, a patient underwent an l4-l5 level anterior column realignment procedure with no reported complications. On an unknown date, the patient also underwent a posterior smith-peterson osteotomy and posterior spinal instrumentation fusion at l3-l5 levels. After posterior procedure, the patient developed right-sided l4 and l5 acute radiculopathy. Ct scan found a medially directed breech of right l4 and left l5 pedicle screws. Revision procedure was completed during the same hospital stay, with resolution of symptoms. No information available about inter body implant used during the acr nor instrumentation products used during posterior procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2020-00018 |
| MDR Report Key | 9681766 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-02-07 |
| 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 CA 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 | NUVASIVE NVM5 SYSTEM |
| Generic Name | STIMULATOR, NERVE |
| Product Code | ETN |
| Date Received | 2020-02-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE |
| Manufacturer Address | 7475 LUSK BOULEVARD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-07 |