This mdr is being submitted due to the reported partial explantation three (3) days after initial placement of the acell device.The surgeon chose to partially explant to address the recurrent hernia repair not due to a malfunction of the device.The device was not returned to acell for further investigation.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with acell's operating procedures and federal, state, and local laws and regulations.
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On (b)(6) 2020, acell, inc.Was notified by a physician that the patient experienced a hernia recurrence.The device implantation surgery was a redo laparoscopic hiatal hernia repair with nissen fundoplicationon on (b)(6) 2020.The patient experienced a second hernia recurrence and was reoperated on (b)(6) 2020, when some of the device was partially explanted but the device was otherwise maintained superiorly and medially.
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