Catalog Number 5444-0-300 |
Device Problems
Fitting Problem (2183); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Date 01/29/2016 |
Event Type
Injury
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested but not made available due hospital policy.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
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Event Description
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Patient was revised as the original implant did not fit and was described as "too big and too thick." the initial surgery was performed in (b)(6) 2015.
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Manufacturer Narrative
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An event regarding a size/fit issue involving a cmf customized implant kit large was reported.The event was confirmed.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the cmf team confirmed that the original implant sat high and proud.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
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Event Description
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Patient was revised as the original implant did not fit and was described as "too big and too thick." the initial surgery was performed in (b)(6) 2015.
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Search Alerts/Recalls
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