Brand Name | TIBIAL RESEC HEAD-LEFT W/ALIG |
Type of Device | GAUGE, DEPTH |
Manufacturer (Section D) |
BIOMET ORTHOPEDICS |
56 e. bell drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
BIOMET ORTHOPEDICS |
56 e. bell drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 6352684 |
MDR Text Key | 68126746 |
Report Number | 0001825034-2017-00883 |
Device Sequence Number | 1 |
Product Code |
HTJ
|
Combination Product (y/n) | N |
Reporter Country Code | EI |
PMA/PMN Number | PEXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
06/30/2017 |
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 Model Number | N/A |
Device Catalogue Number | 32-487556 |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/24/2017 |
Initial Date FDA Received | 02/23/2017 |
Supplement Dates Manufacturer Received | Not provided Not provided 06/16/2017
|
Supplement Dates FDA Received | 03/24/2017 04/11/2017 06/30/2017
|
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
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Patient Age | 72 YR |