Brand Name | TEMPUS CERVICAL PLATE SYSTEM |
Type of Device | SPINAL INTERVERTEBRAL BODY FIXATIO ORTHOSIS |
Manufacturer (Section D) |
NEUROSTRUCTURES, LLC |
16 technology dr. |
ste 132 |
irvine CA 92618 |
|
MDR Report Key | 5053502 |
MDR Text Key | 24996358 |
Report Number | MW5055891 |
Device Sequence Number | 1 |
Product Code |
KWQ
|
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Other
|
Report Date |
08/13/2015 |
3 Devices were Involved in the Event: |
1
2
3
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/31/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 10-03-045 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 42 YR |
|
|