Brand Name | CD HORIZON 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 |
stacie
ziemba
|
1800 pyramid place |
memphis, TN 38132
|
9013963133
|
|
MDR Report Key | 6613815 |
MDR Text Key | 76719643 |
Report Number | 1030489-2017-01457 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 00643169177055 |
UDI-Public | 00643169177055 |
Combination Product (y/n) | N |
Reporter Country Code | EI |
PMA/PMN Number | K122862 |
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,Followup,Followup |
Report Date |
12/22/2017 |
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 Catalogue Number | 7578302 |
Device Lot Number | EM16B005 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/29/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/12/2017 |
Initial Date FDA Received | 06/06/2017 |
Supplement Dates Manufacturer Received | 05/12/2017 12/04/2017
|
Supplement Dates FDA Received | 09/07/2017 12/22/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
Patient Age | 70 YR |
|
|