Brand Name | EQUINOXE REVERSE HUMERAL LINER |
Type of Device | HUMERAL LINER |
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
|
3523771140
|
|
MDR Report Key | 5185181 |
MDR Text Key | 29744060 |
Report Number | 1038671-2015-00620 |
Device Sequence Number | 1 |
Product Code |
KWT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/01/2016 |
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 |
Physician
|
Device Catalogue Number | 320-38-00 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/29/2015 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 10/28/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/01/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
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;
|
|
|