Brand Name | IDUO G2 |
Type of Device | BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM |
Manufacturer (Section D) |
CONFORMIS, INC. |
28 crosby dr. |
bedford MA 01730 |
|
Manufacturer Contact |
karina
snow
|
28 crosby dr. |
bedford, MA 01730
|
7813459195
|
|
MDR Report Key | 5781673 |
MDR Text Key | 49128991 |
Report Number | 3004153240-2016-00147 |
Device Sequence Number | 1 |
Product Code |
NPJ
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K093513 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,study |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
07/11/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/11/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 02/28/2015 |
Device Catalogue Number | M5723INT0600220 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/21/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/13/2014 |
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 | 74 YR |
|
|