Type of Device | SCREW, FIXATION, BONE |
Manufacturer (Section D) |
ACUMED LLC |
5885 nw cornelius pass road |
hillsboro OR 97124 |
|
Manufacturer (Section G) |
ACUMED LLC |
5885 nw cornelius pass road |
|
hillsboro OR 97124 |
|
Manufacturer Contact |
micki
lehman
|
5885 nw cornelius pass road |
hillsboro, OR 97124
|
8886279957
|
|
MDR Report Key | 7022543 |
MDR Text Key | 91807336 |
Report Number | 3025141-2017-00283 |
Device Sequence Number | 1 |
Product Code |
HRS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
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 |
10/26/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/10/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 10/26/2017 |
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 Outcome(s) |
Required Intervention;
|
Patient Age | 32 YR |
|
|