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 MLX MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM manufactured by Nuvasive, Incorporated.
[188118541]
No product has been returned for evaluation as no product malfunction alleged. No xrays or culture results provided.
Patient Sequence No: 1, Text Type: N, H10
[188118542]
A patient underwent a surgical procedure on (b)(6) 2019. As per reporter post-operatively, it was determined the patient had a wound dehiscence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2020-00046 |
| MDR Report Key | 9860121 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-02-20 |
| 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 INC |
| 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 MLX MEDIAL LATERAL EXPANDABLE LUMBAR 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. Other | 2020-03-20 |