Brand Name | OPTETRAK LOGIC FEMORAL COMPONENT POSTERIOR STABILIZED, CEMENTED |
Type of Device | FEMORAL COMPONENT |
Manufacturer (Section D) |
EXACTECH, INC. |
2320 nw 66th ct |
gainesville FL 32653 |
|
Manufacturer (Section G) |
EXACTECH, INC. |
2320 nw 66th ct |
|
gainesville FL 32653 |
|
Manufacturer Contact |
graham
cuthbert
|
2320 nw 66th ct |
gainesville, FL 32653
|
|
MDR Report Key | 6681253 |
MDR Text Key | 110091007 |
Report Number | 1038671-2017-00428 |
Device Sequence Number | 1 |
Product Code |
JWH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Attorney
|
Type of Report
| Initial,Followup |
Report Date |
06/01/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/30/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
|
Device Catalogue Number | 02-010-01-0220 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 06/20/2017 |
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 Treatment Data |
Date Received: 06/30/2017 Patient Sequence Number: 1 |
|
|