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 101-9814 manufactured by Vertiflex Inc..
[183125097]
A report was received that during a follow up appointment the physician noticed poor healing of the incision site. The patient was experiencing redness, drainage at the incision site and increased back pain. An mri revealed a seroma at the incision site. The physician believed it was a localized skin infection and it did not believe the event was procedure related. The patient was given antibiotic and referred to a wound clinic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-01135 |
| MDR Report Key | 9820923 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-10-24 |
| 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 | 101-9814 |
| Catalog Number | 101-9814 |
| Lot Number | 700041 |
| 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 |