FDA Adverse Event
Other
Summary report: N
LEXER CHISEL 8.0/ 1.280
MDR report key: 3487511
·
Received November 12, 2013
Report
- Report Number
- 9613350-2013-02030
- Event Type
- Other
- Date Received
- November 12, 2013
- Date of Event
- October 16, 2013
- Report Date
- October 16, 2013
- Manufacturer
- ZIMMER GMBH
- Product Code
- KDG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AN UPDATED REPORT WILL BE SUBMITTED ONCE THE DEVICE IS RETURNED AND INVESTIGATED. AT THIS TIME OF THE REPORT NO ADDITIONAL INFO HAS BEEN RECEIVED. (B)(4).
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT DURING THE SURGERY THE TIP OF THE BLADE OF THE LEXER CHISEL BROKE WHEN IT HIT A SCREW THAT WAS STUCK IN CEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584035 | LEXER CHISEL 8.0/ 1.280 | LEXER CHISEL | KDG | ZIMMER GMBH | 12794300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |