BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALIX ADVANCE SP ANCHOR (MITEK

    MDR report key: 10459227 · Received August 26, 2020

    Report

    Report Number
    MW5096290
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 24, 2020
    Manufacturer
    DEPUY MITEK, INC.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PARAMETRICS MEDICAL DISTRIBUTED TWO DERMIS ON DEMAND ALLOGRAFTS ((B)(4) SERIAL NUMBERS (B)(4)) TO THE CENTER FOR AMBULATORY SURGERY CENTER ON (B)(6) 2020. BOTH ALLOGRAFTS WERE IMPLANTED DURING A SHOULDER REPAIR BY DR. (B)(6) ON (B)(6) 2020. THE FOLLOWING WERE ALSO IMPLANTED DURING THE PROCEDURE: Y-KNOT SUTURE ANCHORS (LINVATEC) X 3 AND HEALIX ADVANCE SP ANCHORS (MITEK 222425, LOT 6L19804) X2. ON (B)(6) 2020 THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM TO REMOVE ALL THE HARDWARE DUE TO AN INFECTION. THE INCISION WAS OPEN AND RED, AND THE TISSUE WAS INFLAMED DEEP DOWN TO THE REPAIR AND BONE. ALL HARDWARE WAS REMOVED, MINUS THE TIP OF THE HEALIX ADVANCE SP DILATOR TIPS. THE PATIENT WAS ADMITTED TO THE HOSPITAL TO CONTINUE ANTIBIOTICS OVERNIGHT. PARAMETRICS MEDICAL RECEIVED THE COMPLAINT NOTIFICATION ON 07-17-2020 AND NOTIFIED (B)(6) ON 07-20-2020. AT THIS TIME NO ADDITIONAL INFORMATION REGARDING THE PATIENT OR ALLOGRAFTS COULD BE OBTAINED FOLLOWING MULTIPLE ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917135 HEALIX ADVANCE SP ANCHOR (MITEK FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK, INC. 222425 6I19804
    917136 HEALIX ADVANCE SP ANCHOR (MITEK FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK, INC. 222425 6I19804
    917137 Y-KNOT ALL SUTURE ANCHOR (LINVATEC) FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI LINVATEC CORPORATION D/B/A CONMED LINVATEC
    917138 Y-KNOT ALL SUTURE ANCHOR (LINVATEC) FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI LINVATEC CORPORATION D/B/A CONMED LINVATEC
    917139 Y-KNOT ALL SUTURE ANCHOR (LINVATEC) FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI LINVATEC CORPORATION D/B/A CONMED LINVATEC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization