Brand Name | EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 |
Type of Device | ADAPTER TRAY |
Manufacturer (Section D) |
EXACTECH, INC. |
2320 nw 66th court |
gainesville FL 32653 |
|
MDR Report Key | 8120581 |
MDR Text Key | 128917226 |
Report Number | 1038671-2018-00907 |
Device Sequence Number | 1 |
Product Code |
KWT
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
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 | 320-10-00 |
Was Device Available for Evaluation? |
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
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 63 YR |
Patient Weight | 128 |
|
|