Brand Name | DISPOSABLE KIT FOR 1.8MM SHOULDER Q-FIX |
Type of Device | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
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 | 14455269 |
MDR Text Key | 292165413 |
Report Number | 3006524618-2022-00245 |
Device Sequence Number | 1 |
Product Code |
LXH
|
UDI-Device Identifier | 00885556724613 |
UDI-Public | 885556724613 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
06/27/2022 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/19/2024 |
Device Catalogue Number | 25-1810 |
Device Lot Number | 2074995 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/02/2022 |
Initial Date FDA Received | 05/20/2022 |
Supplement Dates Manufacturer Received | 06/24/2022 06/24/2022
|
Supplement Dates FDA Received | 06/27/2022 06/27/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/19/2021 |
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;
|