Brand Name | KYPHX HV-R BONE CEMENT |
Type of Device | CEMENT, BONE, VERTEBROPLASTY |
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 | 6957287 |
MDR Text Key | 89568787 |
Report Number | 1030489-2017-02224 |
Device Sequence Number | 1 |
Product Code |
NDN
|
UDI-Device Identifier | 00643169097865 |
UDI-Public | 00643169097865 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K160983 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
10/18/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/18/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | C01A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 09/22/2017 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|