MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for VERTIFLEX SUPERION IMPLANT manufactured by Vertiflex (r) Incorporated.
[182526863]
The pt was implanted with vertiflex superion interspinous spacer at two levels, l3-4 and l4-5. Over the course of the year the pt did not get the relief from the implant and the implant itself ended the spinous process at each level and had to be removed. The implant was implanted based on the on label use of the product. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093529 |
| MDR Report Key | 9793099 |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-21 |
| Date Added to Maude | 2020-03-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTIFLEX SUPERION IMPLANT |
| Generic Name | PROSTHESIS, SPINOUS PROCESS, SPACER PLATE |
| Product Code | NQO |
| Date Received | 2020-03-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERTIFLEX (R) INCORPORATED |
| Brand Name | VERTIFLEX SUPERION IMPLANT |
| Generic Name | PROSTHESIS, SPINOUS PROCESS, SPACER PLATE |
| Product Code | NQO |
| Date Received | 2020-03-04 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | VERTIFLEX (R) INCORPORATED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2020-03-04 |