FDA Adverse Event
Malfunction
Summary report: N
RADIUS ROD PERSUADER
MDR report key: 1203277
·
Received October 14, 2008
Report
- Report Number
- 9617544-2008-00127
- Event Type
- Malfunction
- Date Received
- October 14, 2008
- Date of Event
- May 19, 2008
- Report Date
- May 19, 2008
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED, AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT "NOTCHED LOCKING BAR NO LONGER HOLDS TENSION. THE INSTRUMENT BECOMES LOOSE ON THE SCREW HEAD AND WILL UNLOCK ITSELF."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIUS ROD PERSUADER | INSTRUMENT | LXH | STRYKER SPINE BORDEAUX | NA | 075819 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |