Brand Name | 3.5MM X 14.0MM LOCKING CORTICAL 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 |
ellie
wood
|
5885 ne cornelius pass road |
hillsboro, OR 97124
|
5035209618
|
|
MDR Report Key | 15970120 |
MDR Text Key | 308506959 |
Report Number | 3025141-2022-00393 |
Device Sequence Number | 1 |
Product Code |
HWC
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K120903 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
12/12/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/13/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | COL-3140-S |
Device Catalogue Number | COL-3140-S |
Device Lot Number | 546410 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/05/2022 |
Date Manufacturer Received | 11/17/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/21/2021 |
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 Race | Asian |
|
|