BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3009495988-2015-00007

    MDR report key: 5225095 · Received November 16, 2015

    Report

    Report Number
    3009495988-2015-00007
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    October 16, 2015
    Report Date
    November 13, 2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS PENDING COMPLETION OF EVALUATION AND ROOT CAUSE IS STILL UNDER INVESTIGATION. ADDITIONAL INFORMATION FOLLOW-UP WILL BE SUBMITTED WHEN THE FOLLOWING INFORMATION BECOMES AVAILABLE: THIS DEVICE IS CURRENTLY REGISTERED UNDER PROCODE BXB AS INDICATED. THIS DEVICE IS CURRENTLY PENDING 510(K) APPROVAL UNDER PROCODE PHL. RELEVANT TESTS - AS DEVICE IS PENDING RETURN TO USA HEADQUARTERS. METHOD, EVALUATION RESULTS AND CONCLUSION - AS DEVICE IS PENDING RETURN TO USA HEADQUARTERS AND ROOT CAUSE IS STILL UNDER INVESTIGATION. REMEDIAL ACTION - ROOT CAUSE IS ONGOING.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE WAS THE ABDUCTION AND ADDUCTION FORCES EXPERIENCED BY THE LEG ASSEMBLY PRODUCED STRESSES HIGHER THAN THE DESIGN STRESS OF THE UDDL. THE DEVICE HAD OVER A MILLION STEPS. REMEDIAL ACTION: REDESIGN UDDL TO LOWER THE PEAK STRESSES WITHOUT CHANGING OVERALL STIFFNESS TO EXTEND DURABILITY BEYOND SERVICE LIFE. SINCE THIS FAILURE MODE REPRESENTS A LOW RISK OF INJURY THE CORRECTIVE ACTIONS WILL BE MADE AT THE NEXT ROUTINE SERVICE PERIOD.

    Description of Event or Problem · 1

    DURING STRAIGHT WALKING, THE UPPER LEFT LEG STRUCTURE BECAME SEPARATED FROM THE DEVICE DURING THE THERAPIST SESSION. THE PATIENT WAS LOWERED INTO A CHAIR AND WAS SAFELY REMOVED FROM THE DEVICE BY THE PHYSICAL THERAPIST WHO WAS WALKING WITH THE PATIENT. THE PATIENT SUSTAINED NO INJURIES AND NO MEDICAL FOLLOW-UP OR INTERVENTION WAS NEEDED. NO THERAPISTS OR THIRD PERSONS HAVE BEEN AFFECTED OR INJURED.

    Description of Event or Problem · 1

    THIS EVENT DID NOT LEAD TO AN INJURY AND THERE HAVE BEEN NO INJURIES REPORTED SINCE THE MDR WAS FILED.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention