Ethnicity - patient involved was a canine.Race - patient involved was a canine.Implanted date: device was not implanted.Explanted date: device was not explanted.\ the actual sample was not returned to the manufacturing facility for evaluation.Therefore, the investigation was based upon the user facility information and the evaluation of five retention samples from the reported lot.The retention samples were evaluated by microscopic investigation, and no defective properties were found.All samples were compliant per iso 10993.The user facility reported similar events from the same product code/lot number combination.See mdrs 9681835-2018-00006, 9681835-2018-00007, and 9681835-2018-00008.A review of the manufacturer inspection record for the reported lot was conducted with no findings.The evaluation of the actual device could not be conducted due to the device not being returned.(b)(4).
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