Brand Name | IUNI |
Type of Device | UNICONDYLAR KNEE REPLACEMENT SYSTEM |
Manufacturer (Section D) |
CONFORMIS, INC. |
28 crosby dr. |
bedford MA 01730 |
|
Manufacturer (Section G) |
CONFORMIS, INC. |
600 research dr. |
|
wilmington MA 01887 |
|
Manufacturer Contact |
karina
snow
|
28 crosby dr. |
bedford, MA 01730
|
7813459195
|
|
MDR Report Key | 5705397 |
MDR Text Key | 46775429 |
Report Number | 3004153240-2016-00125 |
Device Sequence Number | 1 |
Product Code |
HSX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K111916 |
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 |
06/08/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/08/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 05/31/2016 |
Device Catalogue Number | UKA-111-1111 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/13/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/18/2015 |
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 |
|
|