Brand Name | BRYAN CERVICAL DISC SYSTEM |
Type of Device | PROSTHESIS, INTERVERTEBRAL DISC |
Manufacturer (Section D) |
WARSAW ORTHOPEDICS |
2500 silveus crossing |
warsaw IN 46582 |
|
Manufacturer (Section G) |
MEDTRONIC SOFAMOR DANEK |
1800 pyramid place |
|
memphis TN 38132 |
|
Manufacturer Contact |
huzefa
mamoola
|
1800 pyramid place |
memphis, TN 38132
|
9013963133
|
|
MDR Report Key | 4258579 |
MDR Text Key | 5019056 |
Report Number | 1030489-2014-04416 |
Device Sequence Number | 1 |
Product Code |
MJO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P060023 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative,company representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
10/21/2014 |
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 Expiration Date | 03/29/2022 |
Device Catalogue Number | 6474525 |
Device Lot Number | EM13H028 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/04/2014 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/17/2014
|
Initial Date FDA Received | 11/18/2014 |
Supplement Dates Manufacturer Received | Not provided 12/17/2014
|
Supplement Dates FDA Received | 01/15/2015 09/15/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/10/2014 |
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 |
Treatment | ARTIFICIAL DISC |
Patient Age | 00028 YR |