Investigation: due to the fact that the prosthesis is still in-situ, an investigation could not be performed.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause: based on the information available and as a result of our investigation, a product related failure can be excluded.The failure is most probably user or patient related.No capa is necessary.
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