BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELF TAPING ORTHO SCREW

    MDR report key: 3131276 · Received May 9, 2013

    Report

    Report Number
    3131276
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 7, 2013
    Manufacturer
    SYNTHES
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN (B)(6) FEMALE WITH HISTORY OF RHEUMATOID ARTHRITIS AND RIGHT HUMERUS FRACTURE. THE PATIENT HAD AN INTERNAL FIXATION, UNABLE TO DETERMINE WHEN THIS INSERTION TOOK PLACE. PAIN AND DEFORMITY WAS NOTED OF HER RIGHT PROXIMAL HUMERUS, X-RAY READ, NON-UNION WITH DISRUPTION OF INTERNAL FIXATION AND LOOSE SCREWS NOTED. INTRA-OP PER SURGEON, NOTED BROKEN SCREWS AND MENTIONED NONUNION REASONABLE DUE TO EXTREME OSTEOPOROSIS, FIXATION UNABLE TO HOLD WELL. SHE UNDERWENT, REMOVAL OF BROKEN SCREWS AND PLATE, INTERNAL FIXATION OF THE NONUNION OF THE HUMERAL SHAFT AND BONE GRAFT FROM THE ILIAC CREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205192 SELF TAPING ORTHO SCREW BONE SCREW HWC SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R