FDA Adverse Event
Malfunction
Summary report: N
TRILOGY BONE SCREW SELF-TAPPING
MDR report key: 1372282
·
Received February 19, 2009
Report
- Report Number
- 2648920-2009-00003
- Event Type
- Malfunction
- Date Received
- February 19, 2009
- Date of Event
- January 7, 2009
- Report Date
- January 9, 2009
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- JDI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- 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 SURGERY IN EARLY 2009, THE STERILE PACKAGING CAME OFF WITH OUTSIDE PEEL OFF COVER. THEREFORE, POSSIBLY CONTAMINATING STERILE SCREW. THE SCREW WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY BONE SCREW SELF-TAPPING | HIP PROSTHESIS | JDI | ZIMMER MANUFACTURING B.V. | NA | 60610643 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |