The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints.All available information was investigated, and without the device to analyze, a cause for the material protrusion/extrusion could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
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