BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALIGN RADIAL HEAD SYSTEM

    MDR report key: 3240181 · Received July 16, 2013

    Report

    Report Number
    3006742481-2013-00005
    Event Type
    Other
    Date Received
    July 16, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 15, 2013
    Manufacturer
    SKELETAL DYNAMICS LLC
    Product Code
    KWI
    PMA / PMN Number
    K092721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF EVENT. REVIEW OF MANUFACTURING RECORDS DEMONSTRATE THAT ALL MATERIALS MET RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STEM FRACTURED WHILE (B)(6) MALE WAS PUSHING UP FROM THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328614 ALIGN RADIAL HEAD SYSTEM PROSTHESES, ELBOW, HEM, RADIAL KWI SKELETAL DYNAMICS LLC AN0610029R

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other