Brand Name | TOTAL ANKLE SYSTEM - INFINITY® TIBIAL TRAY SIZE 5 |
Type of Device | SMALL JOINT COMPONENT |
Manufacturer (Section D) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
11576 memphis arlington rd |
arlington TN 38002 |
|
Manufacturer (Section G) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
11576 memphis arlington rd |
|
arlington TN 38002 |
|
Manufacturer Contact |
|
1023 cherry road |
memphis, TN 38117
|
901290-566
|
|
MDR Report Key | 5439091 |
MDR Text Key | 38874155 |
Report Number | 1043534-2016-00013 |
Device Sequence Number | 1 |
Product Code |
HSN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123954 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial |
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 |
Other
|
Device Catalogue Number | 33650005 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 02/11/2016 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 02/16/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |