Brand Name | TIBIAL INSERT IMPACTOR TIP |
Type of Device | REUSABLE IMPACTOR COMPONENT |
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 |
thomas
haueter
|
600 technology park drive |
billerica, MA 01821
|
7813459161
|
|
MDR Report Key | 7697980 |
MDR Text Key | 114333543 |
Report Number | 3004153240-2018-00168 |
Device Sequence Number | 1 |
Product Code |
OOG
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K161366 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/18/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | ED-03475 |
Device Lot Number | J160101 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/06/2018 |
Initial Date FDA Received | 07/18/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 73 YR |