Brand Name | BIO-COMP INTER-FERENCE SCRW |
Type of Device | FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE |
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 | 12076258 |
MDR Text Key | 261463001 |
Report Number | 1220246-2021-03341 |
Device Sequence Number | 1 |
Product Code |
MAI
|
UDI-Device Identifier | 00888867035331 |
UDI-Public | 00888867035331 |
Combination Product (y/n) | N |
Reporter Country Code | JO |
PMA/PMN Number | K071176 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
06/28/2021 |
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 Expiration Date | 04/30/2024 |
Device Model Number | BIO-COMP INTER-FERENCE SCRW |
Device Catalogue Number | AR-5028C-09 |
Device Lot Number | 10940892 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/10/2021
|
Initial Date FDA Received | 06/28/2021 |
Date Device Manufactured | 05/08/2020 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|