Brand Name | SALTO TALARIS PROSTHESIS |
Type of Device | ANKLE PROSTHESIS |
Manufacturer (Section D) |
TORNIER S.A.S. |
161 rue lavoisier |
montbonnot saint martin, 38330 |
FR 38330 |
|
Manufacturer Contact |
maud
andriollo-sanchez
|
161 rue lavoisier |
montbonnot saint martin, 38330
|
FR
38330
|
76613500
|
|
MDR Report Key | 6140578 |
MDR Text Key | 61290935 |
Report Number | 3000931034-2016-00211 |
Device Sequence Number | 1 |
Product Code |
HSN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130533 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
11/15/2016 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | NOT REPORTED |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/15/2016 |
Initial Date FDA Received | 12/02/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/30/2017
|
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) |
Other;
|
|
|