MAUDE Adverse Event Report: ACELL, INC. GENTRIX SURGICAL MATRIX

Model Number	PSMX0710
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: GENTRIX SURGICAL MATRIX
• Common Device Name: GENTRIX SURGICAL MATRIX
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney drive; columbia MD 21046
• MDR Report Key: 9683892
• Report Number: 3005920706-2020-00002
• Device Sequence Number: 3171222
• Product Code: FTM
• UDI-Device Identifier: 00386190001851
• UDI-Public: (01)00386190001851(17)210831(10)018982
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K182259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: PSMX0710
• Device Catalogue Number: PSMX0710
• Device Lot Number: 018982
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR