BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBOUND POST OP KNEE

    MDR report key: 8190140 · Received December 21, 2018

    Report

    Report Number
    3003764610-2018-00008
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    November 7, 2018
    Report Date
    December 21, 2018
    Manufacturer
    OSSUR HF
    Product Code
    ITQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESEARCH TO THE COMPLAINT HISTORY OF CASES IDENTIFIED IN TOTAL 7 CASES RELATED TO FAILURE OF THE SECOND TAB OF THE BRACE. NO INJURY OCCURRED IN ANY OF THE CASES POTENTIAL CONTRIBUTING FACTORS TO THIS FAILURE MODE HAVE BEEN IDENTIFIED: RAW MATERIALS: THE RESIN USED TO MOLD THE PLASTIC COMPONENTS, INCLUDING THE BUCKLE, WAS CHANGED BY THE SUPPLIER, THE NEW MATERIAL IS SLIGHTLY LESS ROBUST THAN THE ORIGINAL MATERIAL. DESIGN AND MANUFACTURING: IT WAS FOUND THAT THE MOLDS USED FOR THE PRODUCTION AT THE MANUFACTURING SITE SLIGHTLY DIFFER FROM THE MOLDS USED FOR THE PRODUCTS USED DURING DESIGN/DEVELOPMENT AND VERIFICATION TESTING. (B)(4) HAS BEEN INITIATED AND CORRECTIVE AND PREVENTIVE MEASURES WERE DEFINED.

    Description of Event or Problem · 1

    BUCKLE NO 2 BROKE ON THE DEVICE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031932 REBOUND POST OP KNEE JOINT, KNEE, EXTERNAL BRACE ITQ OSSUR HF B-8381480

    Patients

    Seq Age Sex Outcome Treatment
    1