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 manufactured by Nuvasive.
[178198562]
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
[178198563]
During literature review it was identified that a patient underwent a 2-level anterior column realignment. Approximately one year post-index procedure, patient experienced proximal junctional kyphosis due to proximal junctional screw pull-out, requiring extension of posterior instrumentation from t12 to t9. Patient also sustained a posterior surgical wound infection requiring irrigation and debridement. No information available on posterior instrumentation used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2020-00017 |
| MDR Report Key | 9681527 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-09 |
| 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 COROENT SYSTEM |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| 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. Hospitalization | 2020-02-07 |