Model Number 1192.0020 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/19/2022 |
Event Type
malfunction
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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 issues.
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Event Description
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It was reported there was a revision surgery due to a creo fenestrated mis locking cap that was loose post operatively.This event occurred in austria.
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Event Description
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It was reported there was a revision surgery due to a creo fenestrated mis locking cap that was loose post operatively.This event occurred in austria.
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Manufacturer Narrative
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Four locking caps, one in a screw head, were returned for evaluation because it was not confirmed which locking cap was found loose.Initial observation shows no splaying on the screw head and deformations on the threads of the locking caps.There was visible wear seen in the typical "x" pattern on the bottom of the caps that is consistent with final tightening.The imaging provided shows a lateral view and is unable to establish confirmation that the locking cap had loosened.No determinations can be made as to the cause of the reported issue.
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Search Alerts/Recalls
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