MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study report with the FDA on 2020-03-17 for NUVASIVE BASE INTERFIXATED TITANIUM SYSTEM manufactured by Nuvasive, Incorporated.
[188118004]
No product has been returned for investigation as no product malfunction was alleged. As per reporter infection occurred two months post operative no indication that product caused or contributed to alleged event. Potential adverse events and complications: "... As with any major surgical procedures, there are risks involved in orthopedic surgery. Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection... "
Patient Sequence No: 1, Text Type: N, H10
[188118005]
A patient underwent a surgical procedure on (b)(6) 2018. As per reporter on (b)(6) 2018, the patient developed a deep wound infection. An incision and drainage procedure was preformed anteriorly at l5-s1 on (b)(6) 2018. Patient was reported to have healed on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2020-00042 |
| MDR Report Key | 9845122 |
| Report Source | COMPANY REPRESENTATIVE,STUDY |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2018-10-25 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-17 |
| 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 | MISS VIRNALISA COBACHA |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer G1 | NUVASIVE, INCORPORATED |
| 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 | NUVASIVE BASE INTERFIXATED TITANIUM SYSTEM |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR |
| Product Code | OVD |
| Date Received | 2020-03-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE, INCORPORATED |
| Manufacturer Address | 7475 LUSK BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-17 |