FDA Adverse Event
Injury
Summary report: N
MILLER BONE CEMENT INJECTOR FRONT LOADING CARTRIDGE KIT
MDR report key: 1200659
·
Received October 17, 2008
Report
- Report Number
- 1822565-2008-00703
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 19, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- KIH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT DURING CEMENT INJECTION, THE END OF THE CARTRIDGE JOINTED TO THE CEMENT INJECTOR FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILLER BONE CEMENT INJECTOR FRONT LOADING CARTRIDGE KIT | BONE CEMENT INJECTOR | KIH | ZIMMER, INC. | NA | 60838615 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |