MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-14 for NUVASIVE COROENT THORACOLUMBAR IMPLANTS 6481050006P2 manufactured by Nuvasive.
[128276136]
No product has been returned for investigation nor were radiographs provided to confirm the alleged event. Labeling review: 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... ".
Patient Sequence No: 1, Text Type: N, H10
[128276137]
On (b)(6) 2018, patient underwent an extreme lateral interbody fusion procedure at l4/5 levels. A post-operative examination revealed cage subsidence. On (b)(6) 2018 a revision procedure was performed where existing cage was removed and replaced with autogenous bone graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2018-00165 |
| MDR Report Key | 8069613 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-10-16 |
| Date Mfgr Received | 2018-10-26 |
| Date Added to Maude | 2018-11-14 |
| 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 | MS. YOBANA SANCHEZ |
| Manufacturer Street | 7475 LUSK BOULEVARD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer G1 | NUVASIVE |
| 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 COROENT THORACOLUMBAR IMPLANTS |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC |
| Product Code | PHM |
| Date Received | 2018-11-14 |
| Model Number | 6481050006P2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE |
| Manufacturer Address | 7475 LUSK BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-14 |