Brand Name | VARILIFT-LX |
Type of Device | LUMBAR INTERBODY/FUSION |
MDR Report Key | 10718787 |
MDR Text Key | 214152823 |
Report Number | 3008009850-2020-00006 |
Device Sequence Number | 1 |
Product Code |
MAX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/22/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/22/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Expiration Date | 02/12/2021 |
Device Catalogue Number | CIE3-13-28-00 |
Device Lot Number | 08151006 |
Was Device Available for Evaluation? |
No
|
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 64 YR |
|
|