Brand Name | SUPERION INDIRECT DECOMPRESSION SYSTEM |
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 | 10243190 |
MDR Text Key | 197907526 |
Report Number | 3006630150-2020-02802 |
Device Sequence Number | 1 |
Product Code |
NQO
|
UDI-Device Identifier | 00884662000543 |
UDI-Public | 00884662000543 |
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 |
08/11/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/07/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | 101-9812 |
Device Catalogue Number | 101-9812 |
Device Lot Number | 700043 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 07/13/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|