Brand Name | OMEGA-21 VERTEBRAL FIXATION SYSTEM |
Type of Device | SPINE PROSTHESIS |
Manufacturer (Section D) |
BIOMET SPAIN, S.L. |
calle islas baleares, #50 |
p.o. box 96 |
fuente del jarro, valencia 46988 |
SP 46988 |
|
Manufacturer (Section G) |
BIOMET SPAIN, S.L. |
calle islas baleares, #50 |
p.o. box 96 |
fuente del jarro, valencia 46988 |
SP
46988
|
|
Manufacturer Contact |
christina
arnt
|
56 e. bell dr. |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 9738396 |
MDR Text Key | 199987183 |
Report Number | 0009610576-2020-00001 |
Device Sequence Number | 1 |
Product Code |
MNH
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | SEE H10 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,s |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/20/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/24/2020 |
Initial Date FDA Received | 02/21/2020 |
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
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
|
|