BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL ULNA PLATE, 6-HOLE

    MDR report key: 8225458 · Received January 8, 2019

    Report

    Report Number
    3004369035-2013-00005
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    October 23, 2013
    Report Date
    January 8, 2019
    Manufacturer
    I.T.S. GMBH
    Product Code
    HRS
    UDI-DI
    09120047296530
    PMA / PMN Number
    K130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO AND LOT-NO. WAS PROVIDED, THE DEVICE HISTORY RECORD (DHR) OF THE LAST THREE SHIPMENTS OF A 6-HOLE DISTAL ULNA PLATE (21233-6) THAT WERE SHIPPED TO I.T.S. USA, WERE 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. THE COMPLAINT FORM STATES, THAT THE PATIENT LIFTED A BABY, WHICH DOESN'T COMPLY WITH THE POST-OPERATIVE INSTRUCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DISTAL ULNA PLATE, 6-HOLE WAS DETERMINED TO BE BROKEN POSTOPERATIVELY. ORIGINAL IMPLANT DATE (B)(6) 2013. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21596 DISTAL ULNA PLATE, 6-HOLE DISTAL ULNA PLATE, 6-HOLE HRS I.T.S. GMBH 21233-6 09120047296530

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention