Catalog Number 482802740 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Material Separation (1562); Material Integrity Problem (2978)
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Patient Problems
Bone Fracture(s) (1870); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/09/2017 |
Event Type
malfunction
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Event Description
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It was reported that; this event occurred at the fixation of the l4/5 and the iliac bone of the pelvic fracture.When the final tightening of the blocker at right l4 screw, the surgeon confirmed that the screw head was came off from the screw shaft.After that, the surgeon pulled out the rod and confirmed that the screw of the l5 and iliac bone which was already implanted.The two screw heads were came off from the screw shaft too.Therefore, the three screws were exchanged the new other size screws and the operation was succeeded.
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Manufacturer Narrative
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Visual inspection; device history review; complaint history review; risk assessment.No relevant manufacturing issues were identified as all units met specifications.The screw was returned in 2 pieces, the tulip head was disengaged from the main screw body.It is likely that the reported event of tulip separation took place due to excessive force applied in an incorrect location on the screw.
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Event Description
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It was reported that; this event occurred at the fixation of the l4/5 and the iliac bone of the pelvic fracture.When the final tightening of the blocker at right l4 screw, the surgeon confirmed that the screw head was came off from the screw shaft.After that, the surgeon pulled out the rod and confirmed that the screw of the l5 and iliac bone which was already implanted.The two screw heads were came off from the screw shaft too.Therefore, the three screws were exchanged the new other size screws and the operation was succeeded.
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Search Alerts/Recalls
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