Catalog Number 320-10-00 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Osteolysis (2377)
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Event Date 09/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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This event report was received through clinical data collection activities.Pending evaluation.
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Event Description
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Index surgery: (b)(6) 2018.Glenoid osteolysis possibly related to a fall 1 week after surgery (not documented, no x-rays done), may compromises glenoid fixation (inferior screws).The case report form indicates this event is unlikely related to devices and unlikely related to procedure.
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Manufacturer Narrative
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Void: this complaint was determined to be non-vaild because the reported glenoid osteolysis has been attributed by the surgeon to a patient fall approximately one week post-op.The surgeon also indicated that this event is unlikely related to the devices or the procedure.
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Manufacturer Narrative
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The osteolysis reported in experience was likely the result of the patients reported fall.However, this cannot be confirmed as the devices were not available for evaluation, and no further information was provided.
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Search Alerts/Recalls
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