Sientra complaint #: (b)(4).Sientra received the suspected device from the customer and performed a failure analysis.Upon initial observation the device was found to have a shell failure with no discoloration.The device was unable to be weighed.Upon device inspection, a pinhole rupture was located on the posterior surface.Upon optical inspection, the explant was received ruptured and was submitted for optical analysis.An area with possible striations was identified.Optical microscope images were taken of the area.The observed result of the shell failure is surgical instrument damage.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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