FDA Adverse Event
Death
Summary report: N
CHARITE ARTIFICIAL DISC
MDR report key: 728565
·
Received June 22, 2006
Report
- Report Number
- 1526439-2006-00148
- Event Type
- Death
- Date Received
- June 22, 2006
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- MJO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
A PATIENT WHO HAD BEEN IMPLANTED WITH THE CHARITE ARTIFICIAL DISC. THE DOCUMENTS SENT DEPUY SPINE PROVIDES FEW DETAILS BUT STATES THAT THE PATIENT CONTINUED TO EXPERIENCE PAIR AFTER THE IMPLANT OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHARITE ARTIFICIAL DISC | ARTIFICIAL DISC | MJO | DEPUY SPINE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |