Brand Name | PRODISC L SUPERIOR PLATE, SIZE MEDIUM, 6, STERILE |
Type of Device | PROSTHESIS, INTERVERTEBRAL DISC |
Manufacturer (Section D) |
CENTINEL SPINE, LLC. |
900 airport rd, suite 3b |
west chester PA 19380 |
|
Manufacturer (Section G) |
SYNTHES BRANDYWINE |
1303 goshen parkway |
|
west chester PA 19380 |
|
Manufacturer Contact |
jason
smith
|
900 airport rd, suite 3b |
west chester, PA 19380
|
4848878810
|
|
MDR Report Key | 13792274 |
MDR Text Key | 287354683 |
Report Number | 3007494564-2022-00006 |
Device Sequence Number | 1 |
Product Code |
MJO
|
UDI-Device Identifier | 00843193111791 |
UDI-Public | 00843193111791 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P050010 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/16/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/17/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2023 |
Device Model Number | PDL-M-SP06S |
Device Lot Number | H530811 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/22/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/14/2018 |
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 | 41 YR |
Patient Sex | Female |
|
|