Brand Name | NUVASIVE RELINE SYSTEM |
Type of Device | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM |
Manufacturer (Section D) |
NUVASIVE, INCORPORATED |
7475 lusk boulevard |
92121 CA 92121 |
|
Manufacturer (Section G) |
NUVASIVE, INCORPORATED |
7475 lusk boulevard |
|
san diego CA 92121 |
|
Manufacturer Contact |
geoff
gannon
|
7475 lusk boulevard |
san diego, CA 92121
|
|
MDR Report Key | 11641516 |
MDR Text Key | 244666922 |
Report Number | 2031966-2021-00050 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K143684 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/09/2021 |
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
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/18/2021 |
Initial Date FDA Received | 04/09/2021 |
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;
|