(b)(4).Date sent: 7/26/2023.D4: batch # unk.Additional information was requested and the following was obtained: did any pieces fall into the patient? if yes, were they retrieved? no piece fell into the patient.An analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number 382c31, and no non-conformances were identified as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.
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