Brand Name | OSTEOSPAN MORPHEUS |
Type of Device | FILLER, BONE VOID, CALCIUM COMPOUND |
Manufacturer (Section D) |
BIOGENNIX, LLC |
18007 sky park circle, suite f |
irvine CA 92614 |
|
Manufacturer (Section G) |
BIOGENNIX, LLC |
18007 sky park circle, suite f |
|
irvine CA 92614 |
|
Manufacturer Contact |
miguel
lira
|
18007 sky park circle, suite f |
irvine, CA 92614
|
9492530994
|
|
MDR Report Key | 5953033 |
MDR Text Key | 54879521 |
Report Number | 3008773560-2016-00003 |
Device Sequence Number | 1 |
Product Code |
MQV
|
UDI-Device Identifier | 00812593020644 |
UDI-Public | 00812593020644 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K132377 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/26/2016 |
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 |
Health Professional
|
Device Expiration Date | 12/03/2017 |
Device Model Number | N/A |
Device Catalogue Number | 006-MOR |
Device Lot Number | 10701 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/31/2016
|
Initial Date FDA Received | 09/15/2016 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/03/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|