Catalog Number 481321040 |
Device Problems
Mechanical Problem (1384); Difficult to Remove (1528); Device Slipped (1584); Device Dislodged or Dislocated (2923)
|
Patient Problems
Injury (2348); No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/08/2017 |
Event Type
Injury
|
Event Description
|
It was reported that; screw in an l5/s1 fusion pulled out of the l5 screws bilaterally.Update (b)(6) 2017: correction: the rods pulled out of the l5 screws.The blockers were still engaged in the l5 screws and difficult to remove.
|
|
Manufacturer Narrative
|
Method: visual inspection; device history review; complaint history review; risk assessment; results: the returned device was confirmed to be fractured.Upon device history review, all manufactured units met specification.No relevant manufacturing issues found.The rod was confirmed via visual inspection and xray images.Conclusion: the plausible root cause of the event is user issue.
|
|
Event Description
|
It was reported that; screw in an l5/s1 fusion pulled out of the l5 screws bilaterally.Update (b)(6) 2017: correction: the rods pulled out of the l5 screws.The blockers were still engaged in the l5 screws and difficult to remove.
|
|
Search Alerts/Recalls
|