MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-23 for SUPERION IDS 10MM SUPERION 100-9801 manufactured by Vertiflex, Inc..
[118037505]
After implantation of two superion devices at contiguous levels, the physician reported that one implant was removed at the patient's request. Further communication with the physician on 8/1/2018 revealed that the patient complained that the procedure "made leg pain worse. " the physician also noted that there was no motor or sensory deficit associated with the implantation procedure, and that ct imaging revealed the implant placement to be acceptable. The physician conjectured that, perhaps, the placement of one implant had inadvertently compressed the adjacent level foramina, eliciting the symptoms the patient complained of. He believes removal of one device may resolve the leg pain, but will follow the patient closely.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005882106-2018-00005 |
| MDR Report Key | 7810558 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-23 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-07-22 |
| Date Added to Maude | 2018-08-23 |
| 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 90210 |
| Manufacturer Country | US |
| Manufacturer Postal | 90210 |
| Manufacturer Phone | 4423255934 |
| Manufacturer G1 | VERTIFLEX, INC. |
| Manufacturer Street | 2714 LOKER AVENUE WEST SUITE 100 |
| Manufacturer City | CARLSBAD CA 90210 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90210 |
| 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 | 2018-08-23 |
| Model Number | 10MM SUPERION |
| Catalog Number | 100-9801 |
| Lot Number | 800070 |
| 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 | 2018-08-23 |