MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2020-03-20 for NUVASIVE MODULUS XLIF INTERBODY SYSTEM manufactured by Nuvasive, Incorporated.
[188118379]
No product has been returned for evaluation as no product malfunction reported. Event occurred three months post-operative it is unknown if event is related to surgical procedure.
Patient Sequence No: 1, Text Type: N, H10
[188118380]
A patient underwent a spinal procedure on (b)(6) 2018. On (b)(6) 2019, patient presented with deep vein thrombosis. As per reporter the patient was hospitalized due to the blood clots requiring vein stripping.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2020-00047 |
| MDR Report Key | 9860856 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-03-08 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-20 |
| 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 MODULUS XLIF INTERBODY SYSTEM |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR |
| Product Code | MAX |
| Date Received | 2020-03-20 |
| 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. Hospitalization; 2. Other | 2020-03-20 |