Model Number 1192.0020 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Pain (1994)
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Event Date 08/31/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Neither device or any imaging could be provided for evaluation.No determinations can be made as to the cause of the reported issue.
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Event Description
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It was reported that a revision surgery was done for a creo mis locking cap that had migrated into the muscle post-operatively, causing patient pain.This event occurred in (b)(6).
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Event Description
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It was reported that a revision surgery was done for a creo mis locking cap that had migrated into the muscle post-operatively, causing patient pain.This event occurred in belgium.
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Manufacturer Narrative
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Four creo fenestrated mis locking caps were received.Investigation revealed that all locking caps show wear markings on their bottom surface similar to markings observed in typical final tightening, with the exception of possibly increased wear marks on locking cap bottom outer edges.The exact cause of the reported issue cannot be determined.
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Search Alerts/Recalls
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