Brand Name | ZIMMER TM TOTAL ANKLE TALAR |
Type of Device | HSN |
Manufacturer (Section D) |
ZIMMER, INC. - BUILDING 5 |
1800 west center street |
warsaw IN 46580 |
|
Manufacturer (Section G) |
ZIMMER, INC. - BUILDING 5 |
1800 west center street |
|
warsaw IN 46580 |
|
Manufacturer Contact |
carrie
schneider
|
1800 west center street |
warsaw, IN 46580
|
8006136131
|
|
MDR Report Key | 5612189 |
MDR Text Key | 43794318 |
Report Number | 0001822565-2016-01335 |
Device Sequence Number | 1 |
Product Code |
HSN
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
DISTRIBUTOR,HEALTH PROFESSION |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
04/01/2016 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 04/27/2016 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | N/A |
Device Catalogue Number | 00450001400 |
Device LOT Number | 62453783 |
OTHER Device ID Number | N/A |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 08/18/2016 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 09/29/2013 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | N/A |
Patient TREATMENT DATA |
Date Received: 04/27/2016 Patient Sequence Number: 1 |
|
|