FDA Adverse Event
Other
Summary report: N
DYNESYS PEDICLE SCREW
MDR report key: 1031784
·
Received April 9, 2008
Report
- Report Number
- 9613350-2008-00019
- Event Type
- Other
- Date Received
- April 9, 2008
- Date of Event
- February 20, 2008
- Report Date
- April 9, 2008
- Manufacturer
- ZIMMER GMBH
- Product Code
- NQP
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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 WAS REPORTED: PATIENT WITH BROKEN SCREW AT L3 RIGHT SIDE AND 2 LOOSE SCREWS AT L3 AND L5 LEFT SIDE. CONSTRUCT FROM L3 TO S1. NO PATIENT PAIN. NO BONE GRAFT WAS USED. REVISION SURGERY PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DYNESYS PEDICLE SCREW | NONE | NQP | ZIMMER GMBH | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |