The device sample was not returned for eval at the time of this report.A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.Dhr (device history record) reviewed showed that there were no issues related to this issue neither on the product nor its components during the manufacture of the material.A corrective action cannot be applied since it is not possible to identified the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the implant involved on the incident.Customer complaint cannot be confirmed based only on the info provided, in order to perform a proper investigation is necessary to evaluate the sample involved on the incident.However current production was verified to identify any issue that an lead to the reported defect and no issues were found.If the defective sample becomes available this investigation will be updated with the eval results.
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