MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,foreign, report with the FDA on 2019-03-29 for NUVASIVE COROENT THORACOLUMBAR IMPLANTS 6480855006P2 manufactured by Nuvasive Inc..
[140308896]
No product malfunction alleged, nor were radiographs or images provide to confirm the alleged event. Review of the reported event suggests possible use error caused or contributed to the event. However due to a lack of information provided the root cause cannot be determined at this time. Label review: "... Potential adverse events and complications 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: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity. Rarely, some complications may be fatal... " "... Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s); loss of fixation; nonunion or delayed union; fracture of the vertebra; neurological, vascular or visceral injury... " "... The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient... " "... Ensure the k-wire is not advancing as the path is created over the k-wire. Use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to confirm proper placement and avoid anterior advancement of the k-wire... " "... Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient... " left in situ.
Patient Sequence No: 1, Text Type: N, H10
[140308897]
On (b)(6) 2019, a patient underwent extreme lateral interbody fusion at l1-l5 without a reported issue. Post-operative a ureteral injury was identified. On (b)(6) 2019, a revision procedure was performed to repair the urological damage. The patient recovered and underwent a posterior fixation procedure on (b)(6) 2019 without any reported issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2019-00175 |
| MDR Report Key | 8464441 |
| Report Source | CONSUMER,DISTRIBUTOR,FOREIGN, |
| Date Received | 2019-03-29 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-02-20 |
| Date Mfgr Received | 2019-03-04 |
| Date Added to Maude | 2019-03-29 |
| 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 | MR. GEORGE PANFILI |
| Manufacturer Street | 7475 LUSK BLVD |
| 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 | 2019-03-29 |
| Model Number | 6480855006P2 |
| 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 | 2147483647 | 2019-03-29 |