Model Number 03829650 |
Device Problems
Material Separation (1562); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/24/2021 |
Event Type
malfunction
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Event Description
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It was reported that on (b)(6) 2021 a patient was implanted with a l5-s1 tlif.When repositioning the left l5 screw, the tulip head of the left s1 screw came off.The left s1 screw was successfully removed and replaced.The procedure was completed successfully with an unknown amount of surgical delay.No adverse consequences resulted from this event.
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Manufacturer Narrative
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Visual inspection was performed and confirmed that the tulip disengaged from the screw shank.There is deformation on the base of the tulip, indicating excessive force was applied to tulip during final tightening.The deformation observed on the screw shank bulb indicates that the shank was at a high angulation during final tightening as well.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.The xia surgical technique guide was reviewed and the following was found relevant: use the anti-torque key and the torque wrench or audible torque wrench to final tighten the blockers.The anti-torque key must be used for final tightening.The anti-torque key performs two key functions: ¿ allows the torque wrench to align with the tightening axis.¿ helps to maximize the torque needed to lock the implant assembly.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Line up the two arrows to achieve the final tightening torque of 12nm.If using the audible torque wrench, the blocker is completely tightened to 12nm when the audible torque wrench clicks once.Extra caution is advised in the following cases: ¿ the rod is not horizontally placed into the screw head.¿ the rod is high in the screw head.¿ an acute convex or concave bend is contoured into the rod.Due to the deformation observed on the tulip head and screw shank bulb, the most likely cause of the reported event was determined to be excessive torque during final tightening.The blocker fracture observed also indicates excessive torque was applied to the blocker.This excessive torque may damage/deform the tulip head which can contribute to the reported event.
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Event Description
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It was reported that a patient was implanted with a l5-s1 tlif.When repositioning the left l5 screw, the tulip head of the left s1 screw came off.The left s1 screw was successfully removed and replaced.The procedure was completed successfully with an unknown amount of surgical delay.No adverse consequences resulted from this event.This record captured the xia deformity polyaxial screw.
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Search Alerts/Recalls
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