Brand Name | UNKNOWN TALAR COMPONENT MEDIUM (36MM X 35MM) |
Type of Device | PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED |
Manufacturer (Section D) |
STRYKER GMBH |
bohnackerweg 1 |
postfach |
selzach 2545 |
SZ 2545 |
|
Manufacturer (Section G) |
STRYKER GMBH |
bohnackerweg 1 |
postfach |
selzach 2545 |
SZ
2545
|
|
Manufacturer Contact |
sharon
rivas
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 10759024 |
MDR Text Key | 213944324 |
Report Number | 0008031020-2020-02370 |
Device Sequence Number | 1 |
Product Code |
NTG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P050050 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/29/2020 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | UNK_SEL |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/06/2020
|
Initial Date FDA Received | 10/29/2020 |
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 | 67 YR |
Patient Weight | 87 |