FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC SOFAMOR DANEK MYSTIQUE SYSTEM
MDR report key: 1915417
·
Received November 4, 2010
Report
- Report Number
- 2530154-2010-00002
- Event Type
- Malfunction
- Date Received
- November 4, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 11, 2010
- Manufacturer
- KENSEY NASH CORP.
- Product Code
- KWQ
- PMA / PMN Number
- K041105
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A COMPANY AFFILIATE RECEIVED A MYSTIQUE PLATE REPORT INDICATING THAT A REVISION OF A 1 LEVEL ANTERIOR CERVICAL FUSION WAS REQUIRED. THE PLATE WAS OBSERVED BY AN UNSPECIFIED PARTY TO BE IN MULTIPLE PIECES ON THE ANTERIOR ASPECT OF THE VERTEBRAL BODY. NO PART AND/OR LOT NUMBER INFO WAS PROVIDED. THE TEMPORAL RELATIONSHIP FROM IMPLANTATION TO REVISION WAS NOT PROVIDED. THE OUTCOME WAS NOT AVAILABLE OR PROVIDED. NO ADD'L INFO WAS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC SOFAMOR DANEK MYSTIQUE SYSTEM | KWQ - APPLIANCE, FIXATION, SPINAL | KWQ | KENSEY NASH CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |