The reported event could not be confirmed, because the product was not returned for investigation and also no x-ray images were provided.No lot number was provided, so a review of the specific manufacturing batch record and related quality documents (manufacturing documents, inspection plan, inspection drawing and release report) could not be performed.Therefore, it is also not possible to determine the quantity released for distribution within the affected lot.The sales rep was contacted to provide further insights within this complaint.It was stated that the implant did fit after the surgeon softened the contour around the orbit.No x-ray images after initial surgery or prior to revision surgery are available to study the implant position within the defect.Apart from the information already included in the updated event description, no further information is known.The provided information was not sufficient to determine the root cause of this complaint.According to the related risk management file, possible causes for the hazard ¿poor fit of implant¿ could have been: hcp inexperienced with medpor implants.Insufficient intra-op planning tools.Incorrect selection of implant.Based on the investigation and the corresponding statistical evaluation, there is no indication for a "not correctly working product" or any design, material, or manufacturing related issue.Therefore, no further corrective and/or preventive actions are deemed necessary at this time.The complaint is added to the complaint trend.
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