Brand Name | MERCURY CLASSIC |
Type of Device | MERCURY CLASSIC POLYAXIAL SCREW 8.5MM X 45MM |
Manufacturer (Section D) |
SPINAL ELEMENTS, INC. |
3115 melrose drive, suite 200 |
carlsbad CA 92010 |
|
Manufacturer Contact |
julie
lamothe
|
3115 melrose drive, suite 200 |
carlsbad, CA 92010
|
7606071816
|
|
MDR Report Key | 5841930 |
MDR Text Key | 52070632 |
Report Number | 3004893332-2016-00006 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
PMA/PMN Number | K083230 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
08/02/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Catalogue Number | 62085-045 |
Device Lot Number | 080453 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/21/2016 |
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 07/19/2016 |
Initial Date Manufacturer Received |
07/19/2016 |
Initial Date FDA Received | 08/02/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
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) |
Other;
|
|
|