FDA Adverse Event
Other
Summary report: N
9610617-2008-00002
MDR report key: 1020776
·
Received February 9, 2008
Report
- Report Number
- 9610617-2008-00002
- Event Type
- Other
- Date Received
- February 9, 2008
- Product Code
- KNW
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE 27071ZJ IS BEING RETAINED BY THE HOSP; THEY WILL NOT RELEASE IT FOR EVAL. THEY DID SEND PICTURES. THE PICTURES SHOW THAT THE JAWS ARE NO LONGER ATTACHED TO THE HINGE AND THE HINGE PIN APPEARS TO BE MISSING. THERE ARE ALSO RUST-LIKE DISCOLORATIONS IN THE JAW AREA, WHICH MAY BE CORROSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KNW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |