BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3009495988-2015-00002

    MDR report key: 5021118 · Received August 12, 2015

    Report

    Report Number
    3009495988-2015-00002
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 14, 2015
    Report Date
    August 12, 2015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. LOW RISK FAILURE DUE TO SAFEGUARDS IN PLACE ELIMINATING ANY REALISTIC POSSIBILITY OF PATIENT HARM. DESIGN IMPROVEMENTS WERE IDENTIFIED, WHICH FURTHER INCREASE THE DURABILITY OF THE DEVICE. SINCE THIS FAILURE MODE REPRESENTS A LOW RISK OF INJURY THE CORRECTIVE ACTIONS WILL BE MADE AT THE NEXT ROUTINE SERVICE PERIOD.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED TO MFR FOR EVAL WAS RETAINED. MFR DETERMINED THAT COMPONENT FORMED A CRACK ((B)(4)) UNDER BENDING STRESSES GREATER THAN THE DESIGN LOAD OF THE COMPONENT, AND SUBSEQUENTLY FRACTURED ((B)(4)) DUE TO FATIGUE CAUSING THE LEG STRUCTURE TO SEPARATE FROM THE DEVICE ((B)(4)). PRELIMINARY INVESTIGATION SHOWS THAT THIS MALFUNCTION WAS LIKELY DUE TO A SIMULTANEOUS COMBINATION OF EVENTS. EVIDENCE EXISTS OF DEVICE MISHANDLING ((B)(4)); EVIDENCE EXISTS OF DAMAGE IN SHIPPING; EVIDENCE EXISTS OF DAMAGE FROM PREVIOUS REWORK. RESULTS PENDING COMPLETION OF EVAL AND ROOT CAUSE IS STILL UNDER INVESTIGATION. ADDITIONAL INFO FOLLOW-UP WILL BE SUBMITTED WHEN THE FOLLOWING INFO BECOMES AVAILABLE: (D2B) THIS DEVICE IS CURRENTLY REGISTERED UNDER PROCODE BXB AS INDICATED IN (D2B). THIS DEVICE IS CURRENTLY PENDING 510 (K) APPROVAL UNDER PROCODE PHL. EVAL RESULTS AND CONCLUSION - AS ROOT CAUSE IS STILL UNDER INVESTIGATION. REMEDIAL ACTION - ROOT CAUSE IS ONGOING.

    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.

    Description of Event or Problem · 1

    UPPER LEFT LEG STRUCTURE BECAME SEPARATED FROM THE DEVICE DURING THE PHYSICAL THERAPIST SESSION. THE DEVICE WENT INTO A SAFE MODE STATUS AS DESIGNED. THE PT WAS LOWERED INTO A CHARI AND WAS SAFELY REMOVED FROM THE DEVICE BY THE PHYSICAL THERAPIST WHO WAS WALKING WITH THE PT AS PER TRAINING PROTOCOL. THE PT SUSTAINED NO INJURIES AND NO MEDICAL FOLLOW-UP OR INTERVENTION WAS NEEDED. NO PHYSICAL THERAPISTS, THERAPISTS, OR THIRD PERSONS HAVE BEEN AFFECTED OR INJURED.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR