Brand Name | 2.8MM 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 |
|
Manufacturer (Section G) |
ARTHROCARE CORP. |
7000 w. william cannon |
|
austin TX 78735 |
|
Manufacturer Contact |
holly
topping
|
7000 west william cannon drive |
austin, TX 78735
|
5123913905
|
|
MDR Report Key | 12371149 |
MDR Text Key | 268259883 |
Report Number | 3006524618-2021-00872 |
Device Sequence Number | 1 |
Product Code |
MBI
|
UDI-Device Identifier | 00885556724644 |
UDI-Public | 885556724644 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K133727 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/22/2021 |
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
|
Device Expiration Date | 11/01/2019 |
Device Catalogue Number | 25-2800 |
Device Lot Number | 1173731 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/01/2021 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/05/2021 |
Initial Date FDA Received | 08/26/2021 |
Supplement Dates Manufacturer Received | 12/21/2021
|
Supplement Dates FDA Received | 12/22/2021
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/30/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Other;
|