The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.Medical records have been requested and have not been received by the manufacturer to date.Upon receipt of the medical records, a clinical investigation will be conducted and supplemental report will be filed with the results of the clinical investigations.
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