Brand Name | 8.0MM X 0.0MM STEM |
Type of Device | PROSTHESIS, ELBOW, HEMI-, RADIAL: STEM |
Manufacturer (Section D) |
ACUMED LLC |
5885 ne cornelius pass road |
hillsboro, or |
|
Manufacturer (Section G) |
ACUMED LLC |
5885 ne cornelius pass road |
|
hillsboro, or |
|
Manufacturer Contact |
micki
anderson
|
5885 ne cornelius pass road |
hillsboro, or
|
6279957138
|
|
MDR Report Key | 10425625 |
MDR Text Key | 203500150 |
Report Number | 3025141-2020-00196 |
Device Sequence Number | 1 |
Product Code |
KWI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K131845 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
07/29/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/19/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/03/2024 |
Device Model Number | TR-S0800-S |
Device Catalogue Number | TR-S0800-S |
Device Lot Number | 404488 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/10/2020 |
Date Manufacturer Received | 07/29/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/21/2017 |
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;
|
|
|