MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-05 for NUVASIVE COROENT SYSTEM 1023495 manufactured by Nuvasive Inc..
[182909239]
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
[182909240]
During a literature review it was identified that between the dates of 08/2009 and 12/2010, a patient underwent minimally invasive lateral inter body fusion at l1-l5 levels. A follow-up revision procedure using minimally invasive over-the-top decompression was performed 3 months post-index procedure due to re-stenosis and subsidence. No information on patient condition available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2020-00014 |
| MDR Report Key | 9672901 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-02-05 |
| 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 | MR. YOBANA SANCHEZ |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer G1 | NUVASIVE, INC. |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO 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 COROENT SYSTEM |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2020-02-05 |
| Model Number | 1023495 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE INC. |
| Manufacturer Address | 7475 LUSK BOULEVARD SAN DIEGO 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |