BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALIGNMENT CUP WITH FEMALE PYRAMID

    MDR report key: 1122486 · Received August 13, 2008

    Report

    Report Number
    1836248-2008-00002
    Event Type
    Other
    Date Received
    August 13, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 21, 2008
    Manufacturer
    OSSUR H/F
    Product Code
    ISS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS - REVIEWED 3 YEARS OF COMPLAINTS FILES WITHOUT FINDING A SIMILAR INCIDENT.

    Description of Event or Problem · 1

    "ALIGNMENT CUP FRACTURED. HALF WAS IN THE LAMINATION OF THE SOCKET." "FELL AND HIT HIS HEAD INTO A RAILING. PATIENT EXPERIENCING NECK AND SHOULDER PAIN, BEING SEEN BY A DOCTOR." CPO STATED THAT THE PATIENT WOULD REACH FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALIGNMENT CUP WITH FEMALE PYRAMID ISS OSSUR H/F MCX00204 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other