FDA Adverse Event
Malfunction
Summary report: N
ZAVATION
MDR report key: 5169079
·
Received October 22, 2015
Report
- Report Number
- 3008583793-2015-00002
- Event Type
- Malfunction
- Date Received
- October 22, 2015
- Manufacturer
- ZAVATION
- Product Code
- KWQ
- PMA / PMN Number
- K112533
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A SCREW BACKED OUT POSTOPERATIVELY DUE TO FAILURE OF A 2-LEVEL CERVICAL PLATE LOCKING MECHANISM. THIS WAS CONFIRMED BY X-RAY. NOTE: PATIENT DID NOT MENTION ANY FALLS OR TRAUMA, HAD BEEN LAYING AROUND. THE PATIENT UNDERWENT REVISION SURGERY WITH NO FURTHER POST OPERATIVE COMPLICATIONS REPORTED. THIS IS THE FIRST REPORTED ISSUE OF THIS NATURE, NO TREND AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 699010 | ZAVATION | CERVICAL PLATE 2-LEVEL | KWQ | ZAVATION | 30-0234 | Z1093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |