Catalog Number SAGP0002 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Unspecified Infection (1930)
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Event Date 03/10/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 4 peg mod glen sz 2 cat# sagl2042 lot# 64827338.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00924.
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Event Description
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It was reported that a patient underwent a revision procedure approximately 13 months postimplantion due to infection and bone loss.The implants were removed and a cement spacer was placed while a custom implant is being manufactured.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.The device did not contribute to the infection and/or erosion noted in the prior submission.
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Event Description
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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