FDA Adverse Event
Malfunction
Summary report: N
ZAVATION CERVICAL PLATE
MDR report key: 6757851
·
Received August 1, 2017
Report
- Report Number
- 3008583793-2017-00005
- Event Type
- Malfunction
- Date Received
- August 1, 2017
- Report Date
- July 31, 2017
- Manufacturer
- ZAVATION MEDICAL DEVICE LLC
- Product Code
- KWP
- PMA / PMN Number
- K112533
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PHOTOS OF X RAYS RECEIVED BY (B)(4) IDENTIFY THAT LOCKING SCREW MECHANISMS FAILED, SCREWS HAD WORKED DISLODGED. PHOTO OF DEVICE INDICATES THAT THE DEVICE/SCREWS WERE REMOVED AT SOME POINT. A REVIEW OF THE DHR (DEVICE HISTORY RECORD) REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 536631 | ZAVATION CERVICAL PLATE | 2-LEVEL CERVICAL PLATE | KWP | ZAVATION MEDICAL DEVICE LLC | 30-0230 | Z0823 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |