FDA Adverse Event
Malfunction
Summary report: N
CABLE-READY CABLE GRIP SYSTEM CERCLAGE CABLE WITH NEEDLE AND
MDR report key: 1202413
·
Received October 17, 2008
Report
- Report Number
- 1822565-2008-00709
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- September 5, 2008
- Report Date
- September 17, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- JDQ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
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 WHEN THE SURGEON OPENED THE STERILIZATION PACKAGING, THE PRODUCT WAS NOT INSIDE. ONLY CRIMPS WAS CONTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CABLE-READY CABLE GRIP SYSTEM CERCLAGE CABLE WITH NEEDLE AND | TRAUMA PROSTHESIS | JDQ | ZIMMER, INC. | NA | 61007091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |