MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-11 for SUPERION INDIRECT DECOMPRESSION SYSTEM 101-9812 manufactured by Vertiflex Inc..
[183002898]
A report was received that ten days following the initial implant procedure the patient's incision site appeared infected. The patient was experiencing drainage from the incision site. Along with the incision drainage, the patient also started having increased incisional pain as well as increased calf pain. The physician does not believe the drainage was device related and it's unknown what caused the drainage. The patient was started on antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-01131 |
| MDR Report Key | 9819826 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-11-08 |
| Date Added to Maude | 2020-03-11 |
| 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 | TALAR TAHMASIAN |
| Manufacturer Street | 25155 RYE CANYON LOOP |
| Manufacturer City | VALENCIA CA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Manufacturer Phone | 6619494863 |
| Manufacturer G1 | VERTIFLEX INC. |
| Manufacturer Street | 2714 LOKER AVE. WEST |
| 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 | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE |
| Product Code | NQO |
| Date Received | 2020-03-11 |
| Model Number | 101-9812 |
| Catalog Number | 101-9812 |
| Lot Number | 800191 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERTIFLEX INC. |
| Manufacturer Address | 2714 LOKER AVE. WEST SUITE 100 CARLSBAD CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |