FDA Adverse Event
Other
Summary report: N
CHARITE ARTIFICIAL DISC ENDPLATE, SIZE 4
MDR report key: 621919
·
Received July 20, 2005
Report
- Report Number
- 1526439-2005-00135
- Event Type
- Other
- Date Received
- July 20, 2005
- Report Date
- July 11, 2005
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- MJO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CONTACT REPORTED THAT A PT EXPIRED TWO DAYS AFTER Z-LEVEL CHARITE DISC REPLACEMENT SURGERY. SUSPECTED THAT THE DEATH WAS THE RESULT OT A PULMONARY EMBOLISM OR MYOCARDIAL INFRACTION. FAMILY HAS REFUSED AUTOPSY. THE EVENT WAS NOT REPORTED TO BE DEVICE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHARITE ARTIFICIAL DISC ENDPLATE, SIZE 4 | ARTIFICIAL DISC | MJO | DEPUY SPINE, INC. | NA | WL045C015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other |