Brand Name | 3.5MM X 12MM NON-LOCKING HEXALOBE SCREW |
Type of Device | SCREW, FIXATION, BONE |
Manufacturer (Section D) |
ACUMED LLC |
5885 nw cornelius pass road |
hillsboro OR 97124 9432 |
|
Manufacturer (Section G) |
ACUMED LLC |
5885 nw cornelius pass road |
|
hillsboro OR 97124 9432 |
|
Manufacturer Contact |
micki
lehman
|
5885 nw cornelius pass road |
hillsboro, OR 97124-9432
|
|
MDR Report Key | 6815010 |
MDR Text Key | 83624105 |
Report Number | 3025141-2017-00188 |
Device Sequence Number | 1 |
Product Code |
HRS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K102998 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/21/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/23/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Model Number | 30-0257 |
Device Catalogue Number | 30-0257 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 07/21/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 | 72 YR |
|
|