BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT PLATE, 3.5MM, 7-HOLE

    MDR report key: 8669640 · Received June 5, 2019

    Report

    Report Number
    3004369035-2019-00003
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    February 19, 2019
    Report Date
    June 5, 2019
    Manufacturer
    I.T.S. GMBH
    Product Code
    HRS
    UDI-DI
    09120034304729
    PMA / PMN Number
    K060156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) OF THIS PLATE 21102-7 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. WE ASKED AN EXPERIENCED TRAUMA SURGEON FOR AN ADDITIONAL INDEPENDENT OPINION. IN SUCH FRACTURE TYPE, NORMALLY A FEMUR NAIL IS USED, WHICH CAN DISTRIBUTE THE LOAD BEST. OR EITHER A THICKER PLATE OR FIRST A LONGER 4.5MM STRAIGHT PLATE WITH A SECOND NEUTRALISATION PLATE PLACED VENTRALLY SHOULD BE USED TO INCREASE THE OSCILLATING AREA. THE FRACTURE GAP BETWEEN THE BONE FRAGMENTS CAUSED A PSEUDOARTHROSIS, WHICH LED SUBSEQUENT TO THE IMPLANT FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STRAIGHT PLATE, 3.5MM, 7-HOLE WAS DETERMINED TO BE BROKEN POSTOPERATIVELY. ORIGINAL IMPLANT DATE: (B)(6) 2018. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463132 STRAIGHT PLATE, 3.5MM, 7-HOLE STRAIGHT PLATE, 3.5MM, 7-HOLE HRS I.T.S. GMBH 21102-7 147/13020A 09120034304729

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention