Brand Name | ITOTAL IDENTITY CR |
Type of Device | TOTAL KNEE REPLACEMENT SYSTEM |
Manufacturer (Section D) |
CONFORMIS, INC. |
600 technology park drive |
billerica MA 01821 |
|
Manufacturer (Section G) |
CONFORMIS, INC. |
600 research drive |
|
wilmington MA 01887 |
|
Manufacturer Contact |
emmanuel
nyakako
|
600 technology park drive |
billerica, MA 01821
|
7813459164
|
|
MDR Report Key | 11158792 |
MDR Text Key | 226539720 |
Report Number | 3004153240-2021-00001 |
Device Sequence Number | 1 |
Product Code |
JWH
|
UDI-Device Identifier | M572TCR1011112011 |
UDI-Public | +M572TCR1011112011 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K192198 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/12/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/13/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | TCR101111201 |
Device Catalogue Number | TCR-101-1112 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/14/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/31/2020 |
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;
|
Patient Age | 51 YR |
|
|