Brand Name | PRODISC L SUPERIOR END PLATE MEDIUM 3-STERILE |
Type of Device | PROSTHESIS, INTERVERTEBRAL DISC |
Manufacturer (Section D) |
CENTINEL SPINE |
900 airport road |
suite 3b |
west chester PA 19380 |
|
Manufacturer (Section G) |
HAMMILL MANUFACTURING COMPANY |
360 tomahawk drive |
|
maumee OH 43537 |
|
Manufacturer Contact |
erin
ward
|
900 airport road |
suite 3b |
west chester, PA 19380
|
4848878894
|
|
MDR Report Key | 16690106 |
MDR Text Key | 312787378 |
Report Number | 3007494564-2023-00016 |
Device Sequence Number | 1 |
Product Code |
MJO
|
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 |
Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/27/2023 |
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 | PDL-M-SP03S |
Device Lot Number | 2020-0842 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/17/2023 |
Initial Date Manufacturer Received |
03/07/2023
|
Initial Date FDA Received | 04/06/2023 |
Supplement Dates Manufacturer Received | 03/07/2023
|
Supplement Dates FDA Received | 04/28/2023
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 09/25/2020 |
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 | Male |