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 2016-10-04 for NUVASIVE COROENT THORACOLUMBAR IMPLANTS 5214402 manufactured by Nuvasive, Inc..
[56443371]
No device has been returned for evaluation. It is unknown if patient has neurologic condition which may have affected neuromonitoring. Radiographs were received confirming the malplacement of the initial implant. Action to correct malplacement included placement of a smaller interbody device. The root cause of this reported event is unknown; however, review of the radiographs and operational notes indicated suboptimal interbody placement related to implant size selection or anatomical characteristics of the patient. There is no plan for revision, and the patient will continue to be monitored to determine if the paresis condition resolves.
Patient Sequence No: 1, Text Type: N, H10
[56443372]
On (b)(6) 2016 an interbody device was inserted at l4l5. Intra-operative lateral and ap radiographs showed the device was lateral to the disc space and required adjustment. The cage was replaced with a smaller interbody implant and the case was completed without further difficulties. On 09/06/2016 a neural motor deficit of the patient's left foot was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2016-00072 |
| MDR Report Key | 5998846 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-10-04 |
| Date of Report | 2016-10-04 |
| Date of Event | 2016-09-05 |
| Date Mfgr Received | 2016-09-06 |
| Device Manufacturer Date | 2016-06-10 |
| Date Added to Maude | 2016-10-04 |
| 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 | MR. GEORGE PANFILI |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588825019 |
| 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 COROENT THORACOLUMBAR IMPLANTS |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC |
| Product Code | PHM |
| Date Received | 2016-10-04 |
| Model Number | 5214402 |
| Lot Number | DR7123 |
| Operator | PHYSICIAN |
| 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. Other | 2016-10-04 |