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 COROENT SYSTEM COROENTXL manufactured by Nuvasive.
[183099734]
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. Potential risks identified with the use of this system, which may require additional surgery, include: loss of fixation, pain, discomfort or abnormal sensations due to the presence of the device.. " post-operative warnings: "... Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications. To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques... "
Patient Sequence No: 1, Text Type: N, H10
[183099735]
During a literature review it was identified that between the dates of 08/2009 and 12/2010, patients underwent minimally invasive lateral inter body fusion procedure at l1-l5 levels. During a follow-up, revision procedure using minimally invasive over-the-top decompression was performed due to re stenosis and subsidence. No information on patient condition available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2020-00019 |
| MDR Report Key | 9682289 |
| 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 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 COROENT SYSTEM |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2020-02-07 |
| Model Number | COROENTXL |
| 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 |