Brand Name | 1.8MM Q-FIX ALL SUTURE ANCHOR |
Type of Device | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
Manufacturer (Section D) |
ARTHROCARE CORP. |
7000 w. william cannon |
austin TX 78735 |
|
MDR Report Key | 8414419 |
MDR Text Key | 138922865 |
Report Number | 3006524618-2019-00142 |
Device Sequence Number | 1 |
Product Code |
MBI
|
Combination Product (y/n) | N |
PMA/PMN Number | K133727 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
04/12/2019 |
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
|
Device Catalogue Number | 25-1800 |
Device Lot Number | 2012433 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/21/2019 |
Initial Date FDA Received | 03/12/2019 |
Supplement Dates Manufacturer Received | 04/12/2019
|
Supplement Dates FDA Received | 04/12/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|