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 2020-02-04 for SUPERION INDIRECT DECOMPRESSION SYSTEM 101-9816 manufactured by Vertiflex Inc..
[177536285]
Additional suspect medical device components involved in the event: model # 101-9814, lot# 700036, description: superion ids 14mm.
Patient Sequence No: 1, Text Type: N, H10
[177536286]
A report was received that following the initial implant of a spacer the physician decided to try a larger spacer. The initial spacer was explanted and while trying to implant a larger spacer it was discovered that the implanting instruments were not holding firm. The physician removed everything from the patient and it was determined there was a spinous process fracture at l4. The physician decided to not implant the patient. There were no increased risk factors for a spinous process fracture. There was no unusual or contraindicated anatomy as well as there was no associated signs or symptoms of a spinous process fracture. The patient was reportedly doing well following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-00345 |
| MDR Report Key | 9663256 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-01-06 |
| Device Manufacturer Date | 2019-05-22 |
| Date Added to Maude | 2020-02-04 |
| 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 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 | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE |
| Product Code | NQO |
| Date Received | 2020-02-04 |
| Model Number | 101-9816 |
| Catalog Number | 101-9816 |
| Lot Number | 800130 |
| 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 AVE. WEST SUITE 100 CARLSBAD CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-04 |