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

Model Number	PSMT2025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Hernia (2240)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the reported abscess and hernia recurrence after initial placement of the acell device.The device was not explanted and is performing as expected.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 12/10/2020, acell, inc.Was notified that a gentrix device was debrided due to a hernia recurrence and abscess.The gentrix device was implanted on (b)(4) 2020 due to a ventral hernia.The gentrix was used in a onlay fascial repair without a drain.On (b)(6) 2020, the patient was shown to have hernia recurrence and fluid building.The surgeon reoperated and debrided area around gentrix device.The gentrix device was not explanted but debrided to allow for the bridging of the posterior fascia with another manufacturer's device, phasix.The gentrix device remains in place and is functioning as intended.

• Brand Name: GENTRIX SURGICAL MATRIX THICK
• Common Device Name: GENTRIX SURGICAL MATRIX THICK
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney drive; columbia MD 21046
• MDR Report Key: 11121188
• Report Number: 3005920706-2020-00012
• Device Sequence Number: 19044068
• Product Code: FTM
• UDI-Device Identifier: 00386190001554
• UDI-Public: (01)00386190001554(17)200831(10)013649
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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: No Information
• Device Expiration Date: 08/31/2020
• Device Model Number: PSMT2025
• Device Catalogue Number: PSMT2025
• Device Lot Number: 013649
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHASIX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR