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

Model Number PSMX1015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted due to the reported partial explantation 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 Description

On 12/27/2019, acell, inc.Was notified by a physician that the patient experienced a hernia recurrence.The original surgery in (b)(6) 2019 (exact day unknown) was for an umbilical hernia where the distal to proximal tacking was performed with ethicon securestrap and the acell device.During reoperation in (b)(6) 2019 (exact day unknown) for the recurrent hernia, the physician stated the acell device was partially remodeled and had to be partially explanted to repair the recurrent hernia.Surgeon stated the hernia recurrence occurred due to either contracture retraction or body habitus.

• Brand Name: GENTRIX SURGICAL MATRIX
• Type of Device: GENTRIX SURGICAL MATRIX
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney drive; columbia MD 21046
• Manufacturer (Section G): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer Contact: barry brainard ; 6640 eli whitney dr.; columbia, MD 21046 ; 4109538558
• MDR Report Key: 9630376
• MDR Text Key: 179546057
• Report Number: 3005920706-2020-00001
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00386190001387
• UDI-Public: (01)00386190001387(17)210131(10)015452
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2021
• Device Model Number: PSMX1015
• Device Catalogue Number: PSMX1015
• Device Lot Number: 015452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR