Model Number 48551047 |
Device Problems
Fracture (1260); Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/01/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
H3 other text : device remains implanted.
|
|
Event Description
|
A company representative reported that the tulip of an oasys occiput plate assembly fractured post-operatively.No adverse consequences were reported.Revision surgery has not been performed nor scheduled at this time.
|
|
Manufacturer Narrative
|
H6 coding has been updated to reflect investigation conclusion.H3 other text : device remained implanted.
|
|
Event Description
|
A company representative reported that the tulip of an oasys occiput plate assembly fractured post-operatively.No adverse consequences were reported.Revision surgery has not been performed nor scheduled at this time.
|
|
Search Alerts/Recalls
|