BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTRIX SURGICAL MATRIX

    MDR report key: 9630376 · Received January 25, 2020

    Report

    Report Number
    3005920706-2020-00001
    Event Type
    Injury
    Date Received
    January 25, 2020
    Date of Event
    November 1, 2019
    Report Date
    December 27, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    UDI-DI
    00386190001387
    PMA / PMN Number
    K182259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93455 GENTRIX SURGICAL MATRIX GENTRIX SURGICAL MATRIX FTM ACELL, INC. PSMX1015 015452 00386190001387

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention