Model Number ASKU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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This report is submitted on may 16, 2023.
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Event Description
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Per the surgeon, the magnet was explanted on (b)(6) 2023 (reason for the magnet removal unknown).An osia system was placed on the existing implant under a general anaesthetic.
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Manufacturer Narrative
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Correction: the previous or initial mdr submitted on may 16, 2023 was filed inadvertently.No serious injury has occurred.This report is submitted on may 18, 2023.
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Search Alerts/Recalls
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