Brand Name | SUPERION INDIRECT DECOMPRESSION SYSTEM |
Type of Device | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE |
Manufacturer (Section D) |
BOSTON SCIENTIFIC NEUROMODULATION |
25155 rye canyon loop |
valencia CA 91355 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
cashel road |
|
clonmel |
EI
|
|
Manufacturer Contact |
erik
sherburne
|
25155 rye canyon loop |
valencia, CA 91355
|
7632920920
|
|
MDR Report Key | 19161013 |
MDR Text Key | 340791771 |
Report Number | 3006630150-2024-02539 |
Device Sequence Number | 1 |
Product Code |
NQO
|
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 |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
05/29/2024 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 101-9812 |
Device Catalogue Number | 101-9812 |
Device Lot Number | 28627985 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/02/2024
|
Initial Date FDA Received | 04/22/2024 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/29/2024
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/05/2022 |
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) |
Required Intervention;
|