Catalog Number 482618590 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)
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Patient Problem
Injury (2348)
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Event Date 03/07/2018 |
Event Type
Injury
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Event Description
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It was reported that at the 2 week post operative visit, an x-ray indicated that the tulip popped of the shank of the screw.The patient underwent revision surgery to remove the broken tulip and screw.Another size screw was implanted.
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Manufacturer Narrative
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The customer reported event was confirmed via visual inspection and x rays.The construct was returned with the screw, connector, and 2 blockers.The tulip head of the screw was disengaged from the shank.The connector was still attached to the tulip head with a blocker tightly holding the connector in place.There was deformation on the tulip head locking ring and the head of the screw shank.The provided x ray also shows the tulip head disengaged from the screw shank.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: it was reported that the patient may have fell in rehab facility.It is possible that the force of the fall caused the tulip head to disengage and cause the damage seen on the screw as the tulip head locking ring and the head of the screw shank were both deformed.The most likely root cause is patient fall.
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Event Description
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It was reported that at the 2 week post operative visit, an x-ray indicated that the tulip popped of the shank of the screw.The patient underwent revision surgery to remove the broken tulip and screw.Another size screw was implanted.
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Search Alerts/Recalls
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