BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3173596 · Received June 17, 2013

    Report

    Report Number
    2520274-2013-03498
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. WAS RETURNED AND A LOT NUMBER AND A CATALOG NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, SURGERY FOR AN ORIF OF THE PROXIMAL HUMERUS WAS PERFORMED. ON AN UNKNOWN DATE, BOTH AN X-RAY AND CT SCAN REVEALED A HUMERAL HEAD COLLAPSE. ON (B)(6) 2013, THE PATIENT WAS REVISED TO A HEMI ARTHROPLASTY OF THE SHOULDER. A 3-HOLE PROXIMAL HUMERUS PLATE, 6, 3.7MM CANNULATED LOCKING SCREWS AND 3 CORTEX SCREWS WERE REMOVED. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273743 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention