BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR EBS KNEE JOINT

    MDR report key: 6253317 · Received January 16, 2017

    Report

    Report Number
    9616494-2017-00004
    Event Type
    Malfunction
    Date Received
    January 16, 2017
    Report Date
    November 16, 2016
    Manufacturer
    OTTO BOCK HEALTHCARE GMBH
    Product Code
    ISY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT NOTIFICATION ASSOCIATED WITH THIS DEVICE DESCRIBED THAT TWO SCREWS ARE MISSING. NO SERIOUS INJURIES WERE SUSTAINED AS A RESULT OF THE FAILURE AND NO MEDICAL TREATMENT WAS REQUIRED. THE DEVICE WAS RETURNED TO THE MANUFACTURER ON DECEMBER 27TH, 2016, THE EVALUATION OF THIS DEVICE WAS CONDUCTED AT THE MANUFACTURER'S SERVICE CENTER ON JANUARY 3RD, 2017. AFTER EVALUATION WE CAN CONFIRM THAT TWO BOLTS ARE LOOSENED. AN EXACT REASON FOR THAT COULD NOT BE DETERMINED. NO FALL OR INJURY OCCURRED DUE TO THIS FAILURE, BUT IT COULD HAVE LED TO PATIENT INJURY.

    Description of Event or Problem · 1

    KNEE JOINT WAS SENT IN FOR REPAIR. CUSTOMER STATED THAT TWO SCREWS ARE MISSING. NO FALL OR INJURY OCCURRED DUE TO THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37125 MODULAR EBS KNEE JOINT MODULAR EBS KNEE JOINT ISY OTTO BOCK HEALTHCARE GMBH 3R60=KD

    Patients

    Seq Age Sex Outcome Treatment
    1