FDA Adverse Event
Injury
Summary report: N
CHARITE SLIDING CORE
MDR report key: 1515941
·
Received October 23, 2009
Report
- Report Number
- 1526439-2009-00156
- Event Type
- Injury
- Date Received
- October 23, 2009
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- MJO
- PMA / PMN Number
- P040006
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR EVAL AND THE LOT NUMBERS NOT KNOWN AT THIS TIME. INFO IS LIMITED AT THIS TIME, AND NO CONCLUSIONS CAN BE MADE.
Description of Event or Problem · 1
CHARITE TDR FIRST IMPLANTED AT L5-S1, IN 2004. IN 2009 PT PRESENTED WITH SCIATICA. MRI SCANS PERFORMED AND SHOWED CHARITE CORE HAD SLIPPED POSTERIORLY. PT HAD IMMEDIATE SURGERY TO REMOVE CHARITE AND FUSE. AS SURGICAL INTERVENTION OCCURRED, AN MDR IS FILED TO DOCUMENT THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHARITE SLIDING CORE | ARTIFICIAL DISC | MJO | DEPUY SPINE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention |