BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM PLASTIC SURGERY MATRIX XS

    MDR report key: 2844591 · Received November 16, 2012

    Report

    Report Number
    3005920706-2012-00008
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 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 ITS REVIEW, ACELL IS NOT AWARE OF ANY CLINICAL OF PATHOLOGICAL EVIDENCE INDICATING ITS PRODUCT WAS RELATED TO THE NEED FOR EXPLANT. THIS MDR IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. ON (B)(6) 2012, WIDE EXCISION OF UNDIFFERENTIATED PLEOMORPHIC STAGE III SARCOMA TO LEFT BUTTOCK INVOLVING SKELETAL MUSCLE. PATHOLOGICAL CONFIRMATION OF TUMOR ON (B)(6) 2012. PT HAD PREVIOUSLY RECEIVED CHEMORADIATION THERAPY FOR A PERIOD OF TWO WEEKS. ON (B)(6) 2012, PT INFORMED OF POTENTIAL WOUND COMPLICATIONS WITH A NEW PROCEDURE. PT ELECTED TO MORE FORWARD. PT UNDERWENT RE-WIDE EXCISION OF THE WHOLE WOUND WITH MOBILIZATION OF GLUTEAL TRUNK, SCIATIC NERVE, GLUTEAL MUSCLE FLAP, ADJACENT SOFT TISSUE TRANSFERS OF ABOUT 200 SQ CM, AND PLACEMENT OF MATRISTEM PSMX 9150 SQ CM) AND MATRISTEM MICROMATRIX. ON (B)(6) 2012, SURGERY PERFORMED WITH DEBRIDEMENT OF SKIN, SUBCUTANEOUS TISSUE, DEEP TENDON, MUSCLE BELLY, PERIOSTEUM, AND BONE. STIMULAN PELLETS AND ANTIBIOTIC MIXTURE. SURGEON NOTED THAT EXTENT OF 'RADIATION NECROSIS' WAS SEVERE. INITIAL REPORT MADE BY SURGEON. 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 (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRISTEM PLASTIC SURGERY MATRIX XS FTM, SURGICAL MESH FTM ACELL INC. SM2138-60

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R MATRISTEM MICROMATRIX MM0500: LOT #LP 120-50