FDA Adverse Event
Malfunction
Summary report: N
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
MDR report key: 1025188
·
Received March 31, 2008
Report
- Report Number
- 2184052-2008-00007
- Event Type
- Malfunction
- Date Received
- March 31, 2008
- Date of Event
- March 5, 2008
- Report Date
- March 10, 2008
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- HRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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 48MM PLATE WITH SCREWS INSERTED AT C4 TO C7. ONE LOCKING CAP BROKE DURING ROTATION. THE LOCKING CAP WAS REMOVED FROM SURGICAL WOUND. THE PLATE REMAINS IN THE PATIENT. 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 | 48MM CERVICAL PLATE | HRS | ZIMMER SPINE, INC. | 600-03-148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |