Brand Name | EXACTECH GLENOID REAMER |
Type of Device | REAMER |
Manufacturer (Section D) |
EXACTECH, INC. |
gainsville FL 32653 |
|
MDR Report Key | 9769847 |
MDR Text Key | 181631674 |
Report Number | MW5093366 |
Device Sequence Number | 1 |
Product Code |
HTO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
02/25/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 321-25-38 |
Device Catalogue Number | 321-25-38 |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 02/27/2020 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 78 YR |
|
|