BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALIGN RADIAL HEAD

    MDR report key: 2591878 · Received May 18, 2012

    Report

    Report Number
    3006742481-2012-00004
    Event Type
    Other
    Date Received
    May 18, 2012
    Date of Event
    April 19, 2012
    Report Date
    May 18, 2012
    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 INFO IS INSUFFICIENT TO PERMIT A FINAL CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF PRODUCT SHOWS HIGHLY POLISHED FRACTURE SECTION INDICATING POSSIBILITY OF AN EARLIER TRAUMATIC EVENT. REVIEW OF MFG RECORDS DEMONSTRATES THAT ALL MATERIALS MET RELEASE CRITERIA. SKELETAL DYNAMICS WILL NOTIFY FDA IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    RADIAL HEAD WAS EXPLANTED DUE TO PAIN. STEM PORTION WAS FOUND TO HAVE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIGN RADIAL HEAD RADIAL HEAD PROSTHESIS KWI SKELETAL DYNAMICS, LLC. RADIAL STEM AN0610040

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention