Model Number 1134.0010 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Pain (1994)
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Event Date 10/06/2022 |
Event Type
malfunction
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Event Description
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It was reported there was a revision surgery due to patient pain and found a creo mis locking cap that was loose at l5 post operatively.This event occurred in germany.
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Manufacturer Narrative
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Neither the device or any imaging could be provided for evaluation.No determinations could be made as to the cause of the reported issue.
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Event Description
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It was reported there was a revision surgery due to patient pain and found a creo mis locking cap that was loose at l5 post operatively.This event occurred in germany.
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Manufacturer Narrative
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The device was returned for evaluation.Initial observation shows no visible signs of wear or deformation seen in the hexalobe feature.There was slight wear seen on the bottom of the cap that could indicate it was tightened onto the rod.No determinations could be made as to the cause of the reported issue.
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Search Alerts/Recalls
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