BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVICLE PLATE, 2.5MM, 8-HOLE

    MDR report key: 8225821 · Received January 8, 2019

    Report

    Report Number
    3004369035-2015-00004
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Report Date
    January 8, 2019
    Manufacturer
    I.T.S. GMBH
    Product Code
    HRS
    UDI-DI
    09120034304415
    PMA / PMN Number
    K050852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) OF CLAVICLE PLATE (21121-8) WAS INSPECTED AND SHOWED NO DEVIATIONS. THE QUALITY FORMS MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED NO DEVIATION. THE MATERIAL WAS DETERMINED TO BE CONFORMING AND WAS USED AS IS PER PRODUCT DEVELOPMENT APPROVAL. AS A RESULT OF THE ABOVE AND THE FACT THAT NO DEVICE WAS RETURNED FOR EVALUATION, THIS COMPLAINT IS DEEMED UNCONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLAVICLE PLATE, MEDIAL, 2.5MM, 8-HOLE WAS DETERMINED TO BE BROKEN POSTOPERATIVELY. ORIGINAL IMPLANT DATE UNKNOWN. A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18014 CLAVICLE PLATE, 2.5MM, 8-HOLE CLAVICLE PLATE, 2.5MM, 8-HOLE HRS I.T.S. GMBH 21121-8 147/13442B 09120034304415

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention