Brand Name | THE AVATAR SPINAL SYSTEM |
Type of Device | PEDICLE SCREW SYSTEM |
Manufacturer (Section D) |
LIFE SPINE, INC. |
13951 s quality dr |
huntley IL 60140 |
|
Manufacturer (Section G) |
LIFE SPINE, INC. |
13951 s quality dr |
|
huntley IL 60142 |
|
Manufacturer Contact |
randy
lewis
|
13951 s quality dr |
huntley, IL 60142
|
8478846117
|
|
MDR Report Key | 5809983 |
MDR Text Key | 50066762 |
Report Number | 3004499989-2016-00003 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K111953 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/19/2016 |
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 |
Physician
|
Device Model Number | UNKNOWN |
Device Catalogue Number | 148-003 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/20/2016 |
Initial Date FDA Received | 07/20/2016 |
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) |
Other;
|
Patient Age | 50 YR |
|
|