Brand Name | SUPERION INTERSPINOUS SPACER |
Type of Device | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE |
Manufacturer (Section D) |
VERTIFLEX INC. |
2714 loker ave. west |
suite 100 |
carlsbad CA 92010 |
|
MDR Report Key | 9702655 |
MDR Text Key | 179245145 |
Report Number | 3006630150-2020-00526 |
Device Sequence Number | 1 |
Product Code |
NQO
|
Combination Product (y/n) | N |
PMA/PMN Number | P140004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
03/25/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/16/2020
|
Initial Date FDA Received | 02/12/2020 |
Supplement Dates Manufacturer Received | 02/25/2020
|
Supplement Dates FDA Received | 03/25/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|