The review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.From information provided, based on the product history records, and the recurrence of this type of event for this implant, it is assessed that the event could be due surgeon error when choosing the size of implant.However, the description received did not allow to understand perfectly if the "undersized" implant was replaced by a different size of implant.The complaint issue cannot be clearly identified and surgeon error hypothesis cannot be validated.The cause for the device issue is unknown.The description received did not allow to understand perfectly the surgical steps involved.The investigation found no evidence to indicate a device issue.Root cause is unknown.Device not returned to manufacturer.
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Mobi-c p&f us: undersized.From information provided, "there was a size issue: implant was "undersized".Additional description on this issue was provided: surgeon inserted the implant "and it was undersized.Surgeon then removed it and replaced with appropriate sized implant." reporter also confirmed that the trial were used without any problem.Despite information provided by reporter, surgery was completed successfully with a device of the same size.Delay of 60 min has been reported to remove the implants and reimplant new one.No impact on the patient.Attempts have been made to clarify the fact that all the devices that were billed had the same size than the "undersized" one, but no further information has been provided.
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