MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-24 for SUPERION INDIRECT DECOMPRESSION SYSTEM 100-0110 100-9810 manufactured by Vertiflex, Inc..
[121562155]
Failure to relieve or completely mitigate symptoms is a recognized risk associated with device use, and is disclosed in labeling.
Patient Sequence No: 1, Text Type: N, H10
[121562156]
Patient requested to have her superion implants explanted because she stated that she was "still experiencing pain like before she had the implants. " both implants were successfully removed. No allegation of device defect or malfunction was made. Failure to relieve or completely mitigate symptoms is a recognized risk associated with use of the device, and is disclosed in labeling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005882106-2018-00006 |
| MDR Report Key | 7904239 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-24 |
| Date of Report | 2018-09-24 |
| Date of Event | 2018-08-22 |
| Date Mfgr Received | 2018-08-24 |
| Date Added to Maude | 2018-09-24 |
| 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 ROBERT REITZLER |
| Manufacturer Street | 2714 LOKER AVENUE WEST SUITE 100 |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal | 92010 |
| Manufacturer Phone | 4423255934 |
| Manufacturer G1 | VERITIFLEX, INC. |
| Manufacturer Street | 2714 LOKER AVENUE WEST SUITE 100 |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERION INDIRECT DECOMPRESSION SYSTEM |
| Generic Name | INTERSPINOUS SPACER |
| Product Code | NQO |
| Date Received | 2018-09-24 |
| Model Number | 100-0110 |
| Catalog Number | 100-9810 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERTIFLEX, INC. |
| Manufacturer Address | 2714 LOKER AVENUE WEST SUITE 100 CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-24 |