Brand Name | CD HORIZON SPINAL SYSTEM |
Type of Device | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Manufacturer (Section D) |
MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 pyramid place |
memphis TN 85281 |
|
Manufacturer (Section G) |
MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 pyramid place |
|
memphis TN 85281 |
|
Manufacturer Contact |
stacie
ziemba
|
1800 pyramid place |
memphis, TN 38132
|
9013963133
|
|
MDR Report Key | 8820301 |
MDR Text Key | 152013839 |
Report Number | 1030489-2019-00807 |
Device Sequence Number | 1 |
Product Code |
KWP
|
Combination Product (y/n) | N |
Reporter Country Code | IS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,s |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
07/24/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/24/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/27/2019 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 53 YR |
Patient Weight | 75 |
|
|