Brand Name | IUNI G2 |
Type of Device | UNICONDYLAR REPLACEMENT SYSTEM |
Manufacturer (Section D) |
CONFORMIS, INC. |
600 technology park drive |
billerica, ma |
|
Manufacturer (Section G) |
CONFORMIS, INC. |
600 research drive |
|
wilmington, ma |
|
Manufacturer Contact |
emmanuel
nyakako
|
600 technology park drive |
billerica, ma
|
3459164
|
|
MDR Report Key | 9982560 |
MDR Text Key | 188388614 |
Report Number | 3004153240-2020-00085 |
Device Sequence Number | 1 |
Product Code |
HSX
|
UDI-Device Identifier | M572UKA1111111031 |
UDI-Public | +M572UKA1111111031 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K133256 |
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 |
04/21/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | UKA-111-1111 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/24/2020 |
Initial Date FDA Received | 04/21/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/26/2019 |
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 | 65 YR |
|
|