FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 1662708
·
Received April 13, 2010
Report
- Report Number
- 3005751028-2010-00017
- Event Type
- Injury
- Date Received
- April 13, 2010
- Date of Event
- March 15, 2010
- Report Date
- April 13, 2010
- Manufacturer
- ZIMMER TRABECULAR METAL TECHNOLOGY
- Product Code
- EZX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS.
Description of Event or Problem · 1
EVENT DETAIL: IT WAS REPORTED THAT THE PATIENT WAS REVISED. THE DEVICE WAS IMPLANTED FOR APPROXIMATELY 6 MONTHS. THE ORIGINAL PROCEDURE WAS A STAND ALONE TWO LEVEL ACDF. PRECEDING OR CONTRIBUTING EVENTS: THE PATIENT WAS A SMOKER, EXCESSIVE DRINKER AND POTENTIALLY NON-COMPLIANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | UNKNOWN | EZX | ZIMMER TRABECULAR METAL TECHNOLOGY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |