Brand Name | NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM, COROENT |
Type of Device | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR22 |
Manufacturer (Section D) |
NUVASIVE, INCORPORATED |
7475 lusk blvd. |
san diego CA 92121 |
|
MDR Report Key | 10538982 |
MDR Text Key | 207138074 |
Report Number | 2031966-2020-00184 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
PMA/PMN Number | K203201 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,study |
Type of Report
| Initial,Followup |
Report Date |
09/15/2020 |
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
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/18/2020 |
Initial Date FDA Received | 09/16/2020 |
Supplement Dates Manufacturer Received | 08/18/2020
|
Supplement Dates FDA Received | 02/11/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 8221055P2; 8221055P2 |
Patient Outcome(s) |
Other;
|
Patient Age | 71 YR |
|
|