Brand Name | DBL LOADED 5.5MM PEEK SWVLK |
Type of Device | BIO SOFT TISSUE FIXATN FASTNR |
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 | 19200620 |
MDR Text Key | 341709499 |
Report Number | 1220246-2024-02514 |
Device Sequence Number | 1 |
Product Code |
MAI
|
UDI-Device Identifier | 00888867264564 |
UDI-Public | 00888867264564 |
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | K101823 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/29/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/29/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | DBL LOADED 5.5MM PEEK SWVLK |
Device Catalogue Number | AR-2323PSLC-2-1 |
Device Lot Number | 13109199 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/05/2022 |
Date Manufacturer Received | 10/25/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/13/2021 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |