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 2020-03-18 for NUVASIVE MLX ? MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM NUVASIVE AP manufactured by Nuvasive, Incorporated.
[188118239]
No product has been returned for evaluation nor were radiographs or images provided to confirm the alleged event. It is unknown if patient followed post-operative restrictions or suffered a fall. Patient's bone quality is unknown. Labeling review: "... 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: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)? " warnings, cautions and precautions "... Correct selection of the implant is extremely important. The potential for success is increased by the selection of the proper size of the implant. While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants. Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone. These devices are not designed to withstand the unsupported stress of full weight or load bearing alone... " post-operative warnings "... During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments. Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications... "
Patient Sequence No: 1, Text Type: N, H10
[188118240]
On (b)(6) 2018, patient underwent an l5-s1 transforaminal lumbar interbody fusion. On (b)(6) 2018 the patient reported to the emergency room radicular symptoms and severe pain in the foot. Radiographs revealed a lateral vertebral body fracture and subsidence at l5 level. On (b)(6) 2018 an exploration procedure was performed and scar tissue, ligament and synovium at l5 was discovered. No revision procedure of the vertebral body was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2020-00044 |
| MDR Report Key | 9851251 |
| Report Source | COMPANY REPRESENTATIVE,STUDY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-10 |
| Date of Event | 2018-03-21 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-18 |
| 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 MLX ? MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM NUVASIVE AP |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR |
| Product Code | MAX |
| Date Received | 2020-03-18 |
| 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 | 2020-03-18 |