MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-04 for NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM manufactured by Nuvasive, Inc..
[183100288]
No product has been returned for investigation as no product malfunction was alleged. No radiographs or other images were provided to confirm the alleged event. Based on the information provided a potential incorrect size of implant may have been placed in the patient. Labeling review: "... Warnings, cautions and precautions:the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. Based on the fatigue testing results, when using the nuvasive x-core ivbr system, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. Which may impact on the performance of the system. 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... "
Patient Sequence No: 1, Text Type: N, H10
[183100289]
On (b)(6) 2020, patient underwent a vertebral body replacement procedure. As per reporter during post-operative evaluation, the surgeon determined the implant was placed unsuitable for the patient. On (b)(6) 2020, a revision procedure was performed. No product malfunction was alleged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2020-00012 |
| MDR Report Key | 9668847 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-02-04 |
| 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 ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2020-02-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE, INC. |
| Manufacturer Address | 7475 LUSK BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-04 |