Model Number 93550 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/31/2023 |
Event Type
Injury
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Manufacturer Narrative
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The reported adverse event is associated with a returned device; however, the provided clinical information was reviewed by the manufacturer and no specific device analysis is deemed necessary at this time.Previous product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication.Additionally, there are no indications that a product failure has contributed to the reported issue.Elective removal of an implant is a procedure which requires medical/surgical intervention.The report frequency for these complications is being monitored under cbas complaint and medical device reporting data monitoring plan and the status is updated on a monthly basis.This event is added to this monitoring.This report is submitted on june 23, 2023.
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Event Description
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Per the clinic, it was reported that the patient underwent revision surgery on (b)(6) 2023, in order to convert the patient to a transcutaneous osia implant system.During the procedure, the magnet was explanted and an implant was placed on the internal fixture.
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Search Alerts/Recalls
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