Catalog Number 21-20362 |
Device Problems
Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
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Patient Problem
Discomfort (2330)
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Event Date 08/03/2023 |
Event Type
malfunction
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Event Description
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It was reported that the customer found the mmf screws were loose as if they ere not holding in place.It is not known at this time if there will be or has been a revision surgery to fix the loose screws.No other information is known at this time.
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Manufacturer Narrative
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The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
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Manufacturer Narrative
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Corrected: further evaluation of initial information revealed, that four patients were affected and it is therefore required to address this in separate complaints.This reported case is now documented / covered under (b)(4), complaint (b)(4) and the reported 0008010177-2023-00060 covers the complaint record.
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Event Description
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It was reported that the customer found the mmf screws were loose as if they ere not holding in place.It is not known at this time if there will be or has been a revision surgery to fix the loose screws.No other information is known at this time.
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Search Alerts/Recalls
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