The warnings in the package insert state this type of event can occur.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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The device was returned and analyzed as part of (b)(6).This supplemental report is late information received from (b)(6), which was reported as expected to (b)(6), but inadvertently not recognized as 803 reportable until after the close of the study.According to the study: no failure mode was identified.Additionally, intra-operative observations note, ¿fibrous scar tissue in the region of the fossa and around the condylar prosthesis.¿ these findings probably contributed to device failure.This is report 2 of 2 for the same event.Report 1 of 2 is reported on mfr #0001032347-2014-00051-1.
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