Brand Name | LINKSYMPHOKNEE SYSTEM |
Type of Device | DISTAL FEMORAL AUGMENT MEDIAL-RIGHT/LATERAL-LEFT, SZ. 7-8 TILASTAN, CEMENTED |
Manufacturer (Section D) |
WALDEMAR LINK GMBH&CO.KG |
barkhausenweg 10 |
hamburg, hamburg 22339 |
GM 22339 |
|
Manufacturer Contact |
annerike-tizia
hucklenbroch
|
barkhausenweg 10 |
hamburg, hamburg 22339
|
GM
22339
|
|
MDR Report Key | 17446078 |
MDR Text Key | 320385517 |
Report Number | 3004371426-2023-00067 |
Device Sequence Number | 1 |
Product Code |
HRY
|
UDI-Device Identifier | 04026575257379 |
UDI-Public | 04026575257379 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K211768 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
12/20/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/02/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | 880-307/11 |
Device Catalogue Number | 880-307/11 |
Device Lot Number | 2123225 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 12/20/2022 |
Date Device Manufactured | 10/01/2021 |
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 |
|
|