Brand Name | 28MM ACUTWIST ACUTRAK COMPRESSION SCREW |
Type of Device | SCREW, FIXATION, BONE |
Manufacturer (Section D) |
ACUMED LLC |
5885 ne cornelius pass road |
hillsboro OR 97124 |
|
Manufacturer (Section G) |
ACUMED LLC |
5885 ne cornelius pass road |
|
hillsboro OR 97124 |
|
Manufacturer Contact |
micki
anderson
|
5885 ne cornelius pass road |
hillsboro, OR 97124
|
|
MDR Report Key | 12094402 |
MDR Text Key | 261914129 |
Report Number | 3025141-2021-00064 |
Device Sequence Number | 1 |
Product Code |
HWC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K930834 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
06/09/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/30/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/31/2020 |
Device Model Number | AI-0028-S |
Device Catalogue Number | AI-0028-S |
Device Lot Number | 310761 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 06/09/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/27/2013 |
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 Age | 36 YR |
|
|