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 2020-02-14 for SUPERION INDIRECT DECOMPRESSION SYSTEM 101-9814 manufactured by Vertiflex Inc..
[185259729]
Additional suspect medical device components involved in the event: model # 101-9814, serial # (b)(4), description: superion ids 14mm.
Patient Sequence No: 1, Text Type: N, H10
[185259730]
A report was received that during a two implant surgery while the physician was malleting the second spacer the lamina broke and the spacer advanced further than the physician would like. Since a break was suspected the physician determined the safest thing to do was to remove both spacers. The patient was able to walk following the procedure. The patient was admitted to the er the night of the procedure for pain control. A ct was taken to determine both lamina and spinous process breakage at l3/4 and l4/5. The patient was discharged from the er after the pain was controlled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-00572 |
| MDR Report Key | 9713895 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-01-17 |
| Date Added to Maude | 2020-02-14 |
| 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 | 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 | 2020-02-14 |
| Model Number | 101-9814 |
| Catalog Number | 101-9814 |
| Lot Number | 800149 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-14 |