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 |
|
Manufacturer (Section G) |
VERTIFLEX INC |
|
|
carlsbad CA 92010 |
|
Manufacturer Contact |
talar
tahmasian
|
25155 rye canyon loop |
valencia, CA 91355
|
6619494863
|
|
MDR Report Key | 10095925 |
MDR Text Key | 192385033 |
Report Number | 3006630150-2020-02256 |
Device Sequence Number | 1 |
Product Code |
NQO
|
UDI-Device Identifier | 00884662000543 |
UDI-Public | 00884662000543 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P140004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/28/2020 |
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
|
Device Model Number | 101-9812 |
Device Catalogue Number | 101-9812 |
Device Lot Number | 700027 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/11/2020 |
Initial Date FDA Received | 05/28/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/27/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|