Patient's race and ethnicity were not provided; however, the patient's nationality is (b)(6).The implant driver's lot information was asked but unknown.Request to return reported driver for evaluation was made; however, the reported driver is continued to be used by the dentist and will not be returned.Once the investigation is completed, a supplemental report will be submitted.
|
The driver was requested to return for evaluation; however, the dentist continued to use driver and decided not to return the driver.Instead, an implant was returned along with screw and carrier; however, the returned implant was a hahn tapered implant 7.0 mm x 8 mm instead of an inclusive implant as initially reported.Multiple attempts were made to contact the reported to gain clarification without success.Based on the model of the returned device hahn tapered implant 7.0 mm x 8 mm, this implant is not designed to engage with an inclusive implant driver.It is unknown whether the doctor selected the correct choice of implant to mate with the inclusive driver as reported.However, a visual and microscopic inspection were performed on the returned implant and no defect or non-conformity were found.The device met specifications.There was no visual bone debris nor blood on the implant.This event could not be fully evaluated nor confirmed.This event will be tracked and trended.
|