Brand Name | 4WEB CERVICAL SPINE TRUSS SYSTEM - STAND ALONE |
Type of Device | INTERBODY FUSION DEVICE |
Manufacturer (Section D) |
4WEB, INC. |
2801 network boulevard |
suite 620 |
frisco TX 75034 |
|
Manufacturer (Section G) |
4WEB, INC. |
2801 network boulevard |
suite 620 |
frisco TX 75034 |
|
Manufacturer Contact |
upasana
veturi
|
2801 network boulevard |
suite 620 |
frisco, TX 75034
|
8002857090
|
|
MDR Report Key | 12990401 |
MDR Text Key | 282262233 |
Report Number | 3009189869-2021-00007 |
Device Sequence Number | 1 |
Product Code |
OVE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K190870 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/13/2021 |
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? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/11/2021 |
Initial Date FDA Received | 12/13/2021 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 46 YR |
Patient Sex | Male |