Brand Name | CAPSURE SPINE SYSTEM |
Type of Device | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
Manufacturer (Section D) |
SPINE WAVE, INC. |
3 enterprise drive |
suite 210 |
shelton CT 06484 |
|
Manufacturer (Section G) |
SPINE WAVE, INC. |
3 enterprise dr. |
suite 210 |
shelton CT 06484 |
|
Manufacturer Contact |
ronald
smith
|
3 enterprise drive |
suite 210 |
shelton, CT 06484
|
2039449494
|
|
MDR Report Key | 17996118 |
MDR Text Key | 326386998 |
Report Number | 3004638600-2023-00012 |
Device Sequence Number | 1 |
Product Code |
MNI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K152174 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
10/05/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/05/2023
|
Initial Date FDA Received | 10/24/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
|
|