BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX

    MDR report key: 2316973 · Received October 25, 2011

    Report

    Report Number
    MW5022859
    Event Type
    Injury
    Date Received
    October 25, 2011
    Date of Event
    October 19, 2011
    Report Date
    October 25, 2011
    Manufacturer
    ARTHREX
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFECTION POST ROTATOR CUFF REPAIR WITH BIOCORKSCREW SUTURE ANCHORS. HOSPITALIZED FOR SEVERAL DAYS. SURGERY X 3 FOR IRRIGATION AND DEBRIDEMENT WITH INSERTION OF ANTIBIOTIC BEADS. IV VANCOMYCIN 2 GM Q 12 HR. INFECTION WAS 5 WEEKS POST REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX SUTURE ANCHOR, BIO CORKSCREW MAI ARTHREX 357675

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization