Brand Name | CD HORIZON® SPINAL SYSTEM |
Type of Device | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE |
Manufacturer (Section D) |
MDT SOFAMOR DANEK PUERTO RICO MFG |
barrio marianna rd 909, km0.4 |
humacao PR 00792 |
|
Manufacturer (Section G) |
MDT SOFAMOR DANEK PUERTO RICO MFG |
barrio marianna rd 909, km0.4 |
|
humacao PR 00792 |
|
Manufacturer Contact |
stacie
ziemba
|
1800 pyramid place |
memphis, TN 38132
|
9013963133
|
|
MDR Report Key | 6510501 |
MDR Text Key | 73336876 |
Report Number | 1030489-2017-00950 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | SEE H10 |
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,Followup |
Report Date |
05/11/2018 |
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 | 7078396 |
Device Lot Number | H5327067 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/12/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/27/2017 |
Initial Date FDA Received | 04/21/2017 |
Supplement Dates Manufacturer Received | Not provided 05/10/2017 04/16/2018
|
Supplement Dates FDA Received | 05/21/2017 10/03/2017 05/11/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/09/2016 |
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 |