Brand Name | FLAT CUT TALAR DOME SZ 5 INFINITY ADAPTIS |
Type of Device | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
Manufacturer (Section D) |
WRIGHT MEDICAL TECHNOLOGY INC |
1023 cherry rd |
memphis TN 38117 |
|
Manufacturer (Section G) |
WRIGHT MEDICAL TECHNOLOGY, INC. |
11576 memphis arlington rd |
|
arlington TN 38002 |
|
Manufacturer Contact |
anna
jusinski
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 18119457 |
MDR Text Key | 327945382 |
Report Number | 3010667733-2023-00681 |
Device Sequence Number | 1 |
Product Code |
HSN
|
UDI-Device Identifier | 00889797073097 |
UDI-Public | 00889797073097 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K191393 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Literature |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
01/12/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/13/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | 33680035 |
Device Lot Number | 1684349 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/19/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/19/2020 |
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 Age | 70 YR |
Patient Sex | Male |
|
|