FDA Adverse Event
Malfunction
Summary report: N
CONFIDENCE SPINAL CEMENT SYSTEM
MDR report key: 2193033
·
Received July 22, 2011
Report
- Report Number
- 1526439-2011-00129
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- NDN
- PMA / PMN Number
- K060300
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEPUY SPINE HAS REQUESTED RETURN OF THE DEVICE FOR EVAL. A F/U MEDWATCH REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVAL.
Description of Event or Problem · 1
INTERNATIONAL AFFILIATE REPORTS THE PROXIMAL PART OF THE CEMENT SYSTEM'S TROCAR BROKE WHEN THE DEVICE WAS REMOVED DURING A VERTEBROPLASTY PROCEDURE. THE BROKEN PORTION REMAINS IN THE PT. AS AN UNINTENDED PORTION OF THE DEVICE REMAINS IN THE PT, A MEDWATCH REPORT IS BEING FILED TO DOCUMENT THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONFIDENCE SPINAL CEMENT SYSTEM | BONE CEMENT SYSTEM | NDN | DEPUY SPINE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |