Brand Name | PRODISC C US IMPLANT |
Type of Device | PROSTHESIS, INTERVERTEBRAL DISC |
Manufacturer (Section D) |
CENTINEL SPINE, LLC |
900 airport road, suite 3b |
west chester PA 19380 |
|
Manufacturer (Section G) |
SYNTHES BRANDYWINE |
1303 goshen parkway |
|
west chester PA 19380 |
|
Manufacturer Contact |
erin
ward
|
900 airport road |
suite 3b |
west chester, PA 19380
|
4848878894
|
|
MDR Report Key | 17813221 |
MDR Text Key | 324191845 |
Report Number | 3007494564-2023-00048 |
Device Sequence Number | 1 |
Product Code |
MJO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P070001 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
09/25/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | UNKNOWN |
Device Catalogue Number | N/A |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/18/2023 |
Initial Date Manufacturer Received |
09/06/2023
|
Initial Date FDA Received | 09/25/2023 |
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 | 42 YR |