Model Number 48233535 |
Device Problems
Material Separation (1562); Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/26/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Status and location of the device is unknown.
|
|
Event Description
|
It was reported that the tulips of 9 xia uniplanar screws disengaged from their respective screw shafts intra-operatively.Subsequently, there was a 60 minute delay to surgery as the surgeon removed the screws and rods on both sides to redo the construct.The procedure was completed successfully.This report captures the sixth of the nine screws.
|
|
Manufacturer Narrative
|
B.5 has been corrected following new information received and investigation completion.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed as a valid lot code was not provided and could not be obtained.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker.If devices and / or additional information become available, this investigation will be reopened.An investigation was done for one of the two returned screws which did exhibit tulip disengagement.Summary of this investigation is below: "visual inspection shows that multiple maneuvers were performed simultaneously or consecutively that put excess stress on the screw tulip.Evidence of this is shown in the multiple deformations on the tulip locking ring as well as the deformation left on the screw shank bulb, which was out of line with the tulip axis.Likely cause is due to excessive angulation and excessive force applied as seen in the deformation on the screw and tulip locking ring".Due to the implant not being returned the root cause could not be determined conclusively, however it was most likely due to similar causes as the returned screw.
|
|
Event Description
|
It was initially reported that the tulips of 2 xia uniplanar screws disengaged from their respective screw shafts intra-operatively.However, after additional information received and investigation completion, 8 screw tulips disengaged.Subsequently, there was a 60 minute delay to surgery as the surgeon removed the screws and rods on both sides to redo the construct.The procedure was completed successfully.This report captures the fourth of the eight screws.
|
|
Search Alerts/Recalls
|