Brand Name | OVERWATCH |
Type of Device | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
Manufacturer (Section D) |
SPINAL ELEMENTS, INC |
3115 melrose drive, suite 200 |
carlsbad CA 92010 |
|
Manufacturer Contact |
peter
perhach
|
3115 melrose drive, suite 200 |
carlsbad, CA 92010
|
7606071830
|
|
MDR Report Key | 12902677 |
MDR Text Key | 281579495 |
Report Number | 3004893332-2021-00023 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K161842 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/30/2021 |
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 |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/02/2021 |
Initial Date FDA Received | 11/30/2021 |
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 |
|
|