Catalog Number 03821540 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Mechanical Problem (1384)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/17/2015 |
Event Type
malfunction
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Event Description
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It was reported that; surgeon was performing a scoliosis surgery.Surgeon was derotating with tubes and screws and the screw head broke and separated from the body.Surgeon proceeded to remove that screw and changed by another one.Again, during derotation, the screw was broken.He removed the screw, placed a new one and again, during the rotation, the screw broke.At a total, 3 screws were broken on the attempts.No impact to the patient was caused.Surgery was delayed in 20 minutes, due to the replacement of screws.
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Manufacturer Narrative
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Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: deformation of the screw tulip was confirmed, which suggests that excess torque was applied during the derotation maneuver.However, the surgeon performed the procedure according to the surgical technique, as a review of the correspondence confirms that the event occurred during a derotation maneuver involving multiple suk tubes attached to the screws, clamped together.Conclusion: various surgical factors may have contributed to the event, involving the positioning of the tubes and the surgeon's technique.However, these factors could not be replicated during device evaluation, and as a result, the root cause of the reported event could not be determined conclusively.
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Event Description
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It was reported that; surgeon was performing a scoliosis surgery.Surgeon was derotating with tubes and screws and the screw head broke and separated from the body.Surgeon proceeded to remove that screw and changed by another one.Again, during derotation, the screw was broken.He removed the screw, placed a new one and again, during the rotation, the screw broke.At a total, 3 screws were broken on the attempts.No impact to the patient was caused.Surgery was delayed in 20 minutes, due to the replacement of screws.
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Search Alerts/Recalls
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