FDA Adverse Event
Malfunction
Summary report: N
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
MDR report key: 1025187
·
Received March 31, 2008
Report
- Report Number
- 2184052-2008-00008
- Event Type
- Malfunction
- Date Received
- March 31, 2008
- Date of Event
- February 25, 2008
- Report Date
- March 12, 2008
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- HRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IN 2008, ZIMMER SPINE CONCLUDED THAT A RECALL OF ALL CYCLONE CERVICAL PLATES WOULD BE PERFORMED. THIS NUMBER HAS NOT BEEN ASSIGNED. ZIMMER SPINE WILL SEND A SUPPLEMENTAL REPORT WHEN A NUMBER IS ASSIGNED.
Description of Event or Problem · 1
SURGERY DATE: 2008. A 34MM PLATE WITH SCREWS INSERTED ONTO CERVICAL SPINE. ONE LOCKING CAP BROKE DURING ROTATION. THE FIELD REPRESENTATIVE REPORTED >30 MINUTES OF ADDITIONAL SURGERY TIME WAS NEEDED TO REMOVE THE CYCLONE PLATE, AND BROKEN LOCKING CAP, FROM THE SURGICAL SITE AND INSERT A TRINICA CERVICAL PLATE. SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYCLONE ANTERIOR CERVICAL PLATE SYSTEM | 34MM CERVICAL PLATE | HRS | ZIMMER SPINE, INC. | 600-02-134 | 403022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |