MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-08-14 for SUPERION IDS 10MM SUPERION 100-9810 manufactured by Vertiflex, Inc..
[117130112]
On (b)(6) 2018, this reporter received a telephone call from the wife of a patient who was treated at two (2) levels with the superion ids. She reported that 8-10 days after treatment, her husband (the patient) developed severe hip and leg pain. She stated that removal of the devices is scheduled in the near future, and asked if removal would resolve these symptoms. Subsequent communications with the implanting physician revealed that the patient originally presented with "classic" symptoms of moderate neurogenic claudication associated with lumbar spinal stenosis. Further, he noted that subsequent radiographic imaging establishes that the implants remain "perfectly placed".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005882106-2018-00004 |
| MDR Report Key | 7783079 |
| Report Source | OTHER |
| Date Received | 2018-08-14 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-08-09 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-08-14 |
| 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 | 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 | VERTIFLEX, 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 IDS |
| Generic Name | INTERSPINOUS SPACER |
| Product Code | NQO |
| Date Received | 2018-08-14 |
| Model Number | 10MM SUPERION |
| Catalog Number | 100-9810 |
| Lot Number | 800010 |
| 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 SUITE 100 CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-14 |