BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACL TIGHTROPE RT- ARTHREX INC.

    MDR report key: 5430848 · Received January 21, 2016

    Report

    Report Number
    5430848
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    August 17, 2015
    Report Date
    October 23, 2015
    Manufacturer
    ARTHREX
    Product Code
    HTY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT RIGHT ACL RECONSTRUCTION ON (B)(6) 2015. APPROXIMATELY SIX WEEKS LATER PATIENT DEVELOPED SYMPTOMS OF PAIN, SWELLING, AND LOW GRADE FEVER - SUSPECTED SEPTIC ARTHRITIS. ON (B)(6) 2015 PATIENT UNDERWENT INCISION AND DRAINAGE; SYNOVECTOMY TO TREAT CONDITION. CULTURES WERE POSITIVE FOR PROPIONIBACTERIUM ACNES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43263 ACL TIGHTROPE RT- ARTHREX INC. ACL TIGHTROPE RT HTY ARTHREX 1189810
    43264 TIGHTROPE ABS BUTTON ARTHREX INC. TIGHTROPE ABS BUTTON HTY ARTHREX
    43265 ARTHREX TIGHTROPE ABS ARTHREX TIGHTROPE HTY ARTHREX 1463040
    43329 MENISCAL CINCH -ARTHREX INC. MENISCAL CINCH MBI ARTHREX 1215893

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Life Threatening| R