Brand Name | CD HORIZON SOLERA VOYAGER SPINAL SYSTEM |
Type of Device | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE |
Manufacturer (Section D) |
MEDTRONIC SOFAMOR DANEK USA, INC |
4340 swinea rd |
memphis TN 38118 |
|
Manufacturer (Section G) |
MEDTRONIC SOFAMOR DANEK USA, INC |
4340 swinea rd |
|
memphis TN 38118 |
|
Manufacturer Contact |
tricha
miles
|
1800 pyramid place |
memphis, TN 38132
|
7635140379
|
|
MDR Report Key | 11722522 |
MDR Text Key | 252390745 |
Report Number | 1030489-2021-00524 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K143375 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/26/2021 |
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 | 6642007 |
Device Catalogue Number | 6642007 |
Device Lot Number | KH17H823 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/25/2021 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/01/2021 |
Initial Date FDA Received | 04/26/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/05/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |