BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS FRACTURE IMPLANT UNKNOWN

    MDR report key: 2977970 · Received February 21, 2013

    Report

    Report Number
    9610667-2013-00057
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 24, 2013
    Manufacturer
    TORNIER INC.
    Product Code
    KWS
    PMA / PMN Number
    K082120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULDER ARTHROPLASTY FOR FRACTURE: DOES A FRACTURE-SPECIFIC STEM MAKE A DIFFERENCE? CLINICAL ORTHOPAEDICS AND RELATED RESEARCH 469 (12): 3317 - 3323. THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    ONE INFECTIONS AFTER FRACTURE SPECIFIC STEMS WAS TREATED WITH IMPLANT REMOVAL, ANTIBIOTIC SPACER PLACEMENT AND SECOND STAGE REVERSE TOTAL SHOULDER ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75845 AEQUALIS FRACTURE IMPLANT UNKNOWN NONE KWS TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention