Brand Name | EQUINOXE REVERSE 38MM HUMERAL CONST LINER +2.5 |
Type of Device | LINER |
Manufacturer (Section D) |
EXACTECH, INC. |
2320 nw 66th court |
gainesville FL 32653 |
|
Manufacturer (Section G) |
EXACTECH, INC. |
2320 nw 66th court |
|
gainesville FL 32653 |
|
Manufacturer Contact |
graham
cuthbert
|
2320 nw 66th court |
gainesville, FL 32653
|
3523771140
|
|
MDR Report Key | 8120602 |
MDR Text Key | 128917042 |
Report Number | 1038671-2018-00909 |
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 |
01/17/2019 |
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 Catalogue Number | 320-38-13 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/28/2018
|
Initial Date FDA Received | 11/30/2018 |
Supplement Dates Manufacturer Received | 11/28/2018
|
Supplement Dates FDA Received | 01/17/2019
|
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 | 63 YR |
Patient Weight | 128 |
|
|