Brand Name | INFINITY® |
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 | 6600753 |
MDR Text Key | 76269151 |
Report Number | 1043534-2017-00055 |
Device Sequence Number | 1 |
Product Code |
HSN
|
Combination Product (Y/N) | N |
Reporter Country Code | IT |
PMA/PMN Number | K123954 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,FOREIG |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
05/04/2017 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 05/31/2017 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
OTHER
|
Device MODEL Number | 33600030 |
Device LOT Number | 1333532 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 06/02/2017 |
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Distributor Facility Aware Date | 05/04/2017 |
Event Location |
Hospital
|
Date Manufacturer Received | 05/04/2017 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 01/01/2015 |
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
|
Type of Device Usage |
|
|
|