Catalog Number 2101-0002 |
Device Problems
Leak/Splash (1354); Delivery System Failure (2905)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/07/2015 |
Event Type
malfunction
|
Event Description
|
It was reported that: cement leakage occured while trying augmentation of a pedicle screw.Another cement was available to complete the procedure successfully.
|
|
Manufacturer Narrative
|
Method: device not returned; results: device history review indicated all devices accepted into final stock met specifications.Conclusion: the plausible root cause for the reported event is multifactorial.
|
|
Event Description
|
It was reported that; cement leakage occured while trying augmentation of a pedicle screw.Another cement was available to complete the procedure successfully.
|
|
Search Alerts/Recalls
|