Brand Name | IMPL DELIVERY SYS,DISTAL BICEPS REPR |
Type of Device | PLATE, FIXATION, BONE |
Manufacturer (Section D) |
ARTHREX, INC. |
1370 creekside boulevard |
naples FL 34108 1945 |
|
Manufacturer (Section G) |
ARTHREX, INC. |
1370 creekside boulevard |
|
naples FL 34108 1945 |
|
Manufacturer Contact |
|
MDR Report Key | 15570830 |
MDR Text Key | 306898991 |
Report Number | 1220246-2022-05574 |
Device Sequence Number | 1 |
Product Code |
HRS
|
UDI-Device Identifier | 00888867026476 |
UDI-Public | 00888867026476 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K062747 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
10/10/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/10/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | IMPL DELIVERY SYS,DISTAL BICEPS REPR |
Device Catalogue Number | AR-2260 |
Device Lot Number | 14924211 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 09/19/2022 |
Date Device Manufactured | 02/09/2022 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|