Model Number 482677580 |
Device Problems
Mechanical Problem (1384); Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/04/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that during final tightening a xia serrato polyaxial screw tulip disengaged from the screw shaft intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with a 5 minute surgical delay.
|
|
Manufacturer Narrative
|
Visual inspection confirmed that the tulip is disengaged from the screw shank.There is deformation in multiple locations on tulip locking ring.Screw shank bulb has deformation from rod biased to the outer edge of bulb head.There is also deformation on the locking teeth of screw adjacent to the deformation on bulb head.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.It was reported that rod was fully reduced and that the torque wrench and counter torque key were used for final tightening to 12nm.Based on the damage seen on the locking ring and the screw shank bulb, the most likely root cause is over angulation applied to the screw/tulip interface causing the tulip to disengage during final tightening.
|
|
Event Description
|
It was reported that during final tightening a xia serrato polyaxial screw tulip disengaged from the screw shaft intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with a 5 minute surgical delay.
|
|
Search Alerts/Recalls
|