FDA Adverse Event
Malfunction
Summary report: N
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
MDR report key: 1025189
·
Received March 31, 2008
Report
- Report Number
- 2184052-2008-00006
- Event Type
- Malfunction
- Date Received
- March 31, 2008
- Date of Event
- March 3, 2008
- Report Date
- March 6, 2008
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- HRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, 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 16MM PLATE WITH SCREWS INSERTED AT C6/7. ONE LOCKING CAP BROKE DURING ROTATION. THE FIELD REP REPORTED BETWEEN 10 AND 30 MINS OF ADD'L SURGERY TIME WAS NEEDED TO REMOVE THE CYCLONE PLATE FROM THE SURGICAL SITE AND INSERT A NEW PLATE. SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYCLONE ANTERIOR CERVICAL PLATE SYSTEM | 16MM CERVICAL PLATE | HRS | ZIMMER SPINE, INC. | 600-01-116 | 261982 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |