BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM PLASTIC SURGERY MATRIX XS

    MDR report key: 2844624 · Received November 16, 2012

    Report

    Report Number
    3005920706-2012-00011
    Event Type
    Injury
    Date Received
    November 16, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ACELL INC.
    Product Code
    FTM
    PMA / PMN Number
    K041140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACELL HAS SPOKEN TO SURGEON AND REVIEWED RELEVANT MEDICAL RECORDS. BASED ON IT'S REVIEW, ACELL IS NOT AWARE OF ANY CLINICAL OR PATHOLOGICAL EVIDENCE INDICATING ITS PRODUCT WAS RELATED TO THE NEED FOR EXPLANT. ON (B)(4) 2012, RADIATION CONSIDERED. ON (B)(4) 2012, SURGICAL INTERVENTION WITH OPEN BIOPSY OF AREA AROUND THE ILIAC LYMPHATIC CHAIN OVER THE RIM OF THE PELVIS; MOBILIZATION OF THE ILIAC WITH THE GLUTEAL TRUNK TO PRESERVE POSTERIOR FLAP; MOBILIZATION OF THE GLUTEAL BRANCHES OFF THE SCIATIC NERVE; LEFT HEMIPELVECTOMY AND A GLUTEAL FLAP; AND APPLICATION OF MATRIXSTEM 150 SQ CM FOR ADD'L STRENGTH DUE TO POOR TRANSVERSALIS FACIA AND ABDOMINAL MUSCLES. PATHOLOGY OF BIOPSY CONFIRMS DEDIFFERENTIATED MYXOID LIPOSARCOMA. DEVICE WAS USED IN AN OFF LABEL ONCOLOGIC SURGICAL PROCEDURE. THE SAFETY AND EFFECTIVENESS OF THE DEVICE FOR THIS INDICATION HAVE NOT BEEN DEMONSTRATED AND THERE IS NO FDA CLEARANCE/APPROVAL FOR THIS APPLICATION. ACELL IS IN THE PROCESS OF CONDUCTING A COMPLAINT INVESTIGATION.

    Description of Event or Problem · 1

    ACELL PRODUCT WAS IMPLANTED INTO PT ON (B)(6) 2012. THIS PRODUCT WAS LATER EXPLANTED DURING A PROCEDURE ON AN UNK DATE. (ACELL REP WAS NOT PRESENT DURING EXPLANT AND MEDICAL RECORDS EVALUATED BY ACELL DO NOT INDICATE WHEN EXPLANT OCCURRED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRISTEM PLASTIC SURGERY MATRIX XS FTM, SURGICAL MESH FTM ACELL INC. SM1561-60

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R