FDA Adverse Event
Injury
Summary report: N
CHARITE ARTIFICIAL DISC, SIZE UNK
MDR report key: 1056096
·
Received May 23, 2008
Report
- Report Number
- 1526439-2008-00111
- Event Type
- Injury
- Date Received
- May 23, 2008
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- MJO
- PMA / PMN Number
- p040006
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CONTACT WITH FDA FOUND THAT THE REPORTING PERSON REQUESTED THAT THEIR CONTACT INFO NOT BE SHARED WITH DEPUY SPINE. LITTLE INFO IS KNOWN AT THIS TIME. NO CONNECTION CAN BE MADE BETWEEN THE REPORTED EVENT AND ANY SHORTCOMING OF THE DEVICE OR INFO SUPPLIED WITH THE DEVICE AT THIS TIME.
Description of Event or Problem · 1
DEPUY SPINE INC REC'D A LETTER FROM FDA IN REGARD TO A REPORTED ADVERSE OUTCOME. PT REPORTED BEING IMPLANTED WITH A CHARITE ARTIFICIAL DISC IN EARLY 2006. PT CLAIMS THAT THE DEVICE HAS MIGRATED AND IS HAVING PAIN. CLAIMS THAT SURGICAL INTERVENTION MAY BE REQUIRED TO ADDRESS THE SITUATION. AS AN ADVERSE OUTCOME HAS BEEN REPORTED, AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHARITE ARTIFICIAL DISC, SIZE UNK | ARTIFICIAL DISC | MJO | DEPUY SPINE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |