BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSUR ALUMINUM CRUTCH

    MDR report key: 1365069 · Received March 26, 2009

    Report

    Report Number
    2020250-2009-00001
    Event Type
    Injury
    Date Received
    March 26, 2009
    Date of Event
    March 6, 2009
    Report Date
    March 23, 2009
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IPR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE CRUTCH SHOWS THAT IT IS BROKEN INTO TWO PARTS AT THE UPPER CONNECTION BOLT WHERE THE UPPER PIECE IS ATTACHED TO THE CENTER TUBE. THE BASE PART OF THE CRUTCH IS ALSO VISIBLY BENT BETWEEN RUBBER TIP OF THE CENTER TUBE AND THE LOWER CONNECTION TO THE UPPER PIECE. THE FRACTURE SURFACE IS CLEAN, AND SHOWS CLEAR CHARACTERISTICS OF OVERLOAD (45 DEGREES FRACTURE). IT CAN CLEARLY BE SEEN THAT THE ORIGIN OF FRACTURE IS ON ONE SIDE, AND IT THEN PROPAGATES ACROSS TO THE OTHER SIDE. THIS SUGGEST THAT THE CRUTCH EXPERIENCED A SINGLE VERY HIGH LOAD ON THE SIDE THAT RESULTED IN THE OBSERVED FAILURE. LINKING THESE OBSERVATIONS (THE FRACTURE AND THE BEND OF THE BOTTOM PART OF THE CENTER TUBE) TO ACTUAL SCENARIOS BUT IT IS CLEAR THAT THE CRUTCH WAS NOT IN NORMAL USE AT THE TIME OF FAILURE. TWO POSSIBLE SCENARIOS ARE THAT: THE USER WAS STANDING UP AND USED THE SIDE OF THE CRUTCH TO SUPPORT HERSELF AND THE USER FELL AND LANDED ON THE SIDE OF THE CRUTCH AND THIS IS A MORE LIKELY EXPLANATION. THIS IS THEREFORE CONSIDERED AN ISOLATED INCIDENT THAT HAS OCCURRED AS A RESULT OF ABNORMALLY HIGH FORCES AND FORCE DIRECTION. THIS IS NOT EXPECTED TO HAVE HAPPENED AS A RESULT OF INTENDED USE. OSSUR HAS NOT RECEIVED COMPLAINT OF THIS NATURE BEFORE.

    Description of Event or Problem · 1

    PT WAS ISSUED PEDIATRIC CRUTCHES FROM SURGICAL CENTER. SHE WAS AT HOME AND WAS ENTERING THE BATHROOM WHEN SHE STATES THE CRUTCH BROKE AND SHE FELL AND HIT THE BACK OF HER HEAD ON THE EDGE OF THE BATHTUB. SHE SAW ANOTHER DOCTOR IN 2009: DR. ORDERED A CT SCAN OF HER HEAD, AND X-RAYS OF LUMBAR SPINE. THE FACILITY HAS REPLACED THE CRUTCHES WITH A NEW SET OF THE SAME PEDIATRIC CRUTCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSSUR ALUMINUM CRUTCH OSSUR ALUMINUM CRUTCHES IPR OSSUR AMERICAS R8033PR

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention