BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICELOCK CLUTCH

    MDR report key: 1448855 · Received August 14, 2009

    Report

    Report Number
    1836248-2009-00002
    Event Type
    Other
    Date Received
    August 14, 2009
    Date of Event
    June 17, 2009
    Report Date
    July 10, 2009
    Manufacturer
    OSSUR H/F
    Product Code
    ISS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE REPORTED COUNTER CLOCKWISE SPIN CAN OCCUR IF THE CLUTCH MECHANISM IS NOT TORQUED TO THE FORCE SPECIFIED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    "PT WALKED 8 BLOCKS TO GYM. WHILE ENTERING THE GYM AND GOING THROUGH THE DOOR, HE CAME OUT OF HIS LEG AND FELL ONTO HIS PROSTHESIS AND DISLOCATED HIS SHOULDER. HE WAS IN THE HOSPITAL FOR 10 DAYS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICELOCK CLUTCH ISS OSSUR H/F L-211000 HF081111

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization