Brand Name | INBONE(R) |
Type of Device | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
Manufacturer (Section D) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
11576 memphis arlington rd |
38002 |
|
Manufacturer (Section G) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
11576 memphis arlington rd |
|
38002 |
|
Manufacturer Contact |
matthew
parrish
|
1023 cherry road |
901451-631
|
|
MDR Report Key | 6735770 |
MDR Text Key | 80788688 |
Report Number | 1043534-2017-00079 |
Device Sequence Number | 1 |
Product Code |
HSN
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K051023 |
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,Followup |
Report Date |
06/27/2017 |
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 Model Number | 200009901 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 06/27/2017 |
Event Location |
Home
|
Initial Date Manufacturer Received |
06/27/2017 |
Initial Date FDA Received | 07/24/2017 |
Supplement Dates Manufacturer Received | 05/30/2018
|
Supplement Dates FDA Received | 05/31/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | 62 YR |
|
|