Brand Name | INBONE(R) TALAR DOME |
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
|
901451-631
|
|
MDR Report Key | 5967722 |
MDR Text Key | 55322682 |
Report Number | 1043534-2016-00106 |
Device Sequence Number | 1 |
Product Code |
HSN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K100886 |
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,Followup |
Report Date |
09/21/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 220220903 |
Device Lot Number | 1550740 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/13/2016 |
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 08/30/2016 |
Initial Date Manufacturer Received |
08/30/2016
|
Initial Date FDA Received | 09/21/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 02/24/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 45 YR |
|
|