The reported event was not confirmed ¿ since no product or other evidences were available.Review of complaint history, labelling and capa databases could not be performed since no lot.No was communicated.The risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).More detailed information about the complaint event, e.G.Results of surgeon¿s pre-operative tests, must be available in order to determine the root cause of the complaint event.Pre-operative functional testing is required in the labelling.Potential misalignment of products, causing mis drilling with damage of implants, can easily be detected during required functional check prior to use.With available information root cause for alleged mis drilling could not be determined.In case the instrument and / or other essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.H3 other text : device disposition unknown.
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