BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAIGHT COMPRESSION PLATE, 10-HOLE

    MDR report key: 8572272 · Received May 2, 2019

    Report

    Report Number
    3004369035-2017-00051
    Event Type
    Injury
    Date Received
    May 2, 2019
    Report Date
    May 2, 2019
    Manufacturer
    I.T.S. GMBH
    Product Code
    HRS
    UDI-DI
    09120034309977
    PMA / PMN Number
    K060156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) OF THE STRAIGHT COMPRESSION PLATE (21105-10) 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 STRAIGHT COMPRESSION PLATE, 10-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
    366484 STRAIGHT COMPRESSION PLATE, 10-HOLE STRAIGHT COMPRESSION PLATE, 10-HOLE HRS I.T.S. GMBH 21105-10 09120034309977

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention