BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTICAL SCREW, D=4.5MM

    MDR report key: 8225941 · Received January 8, 2019

    Report

    Report Number
    3004369035-2015-00072
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    February 6, 2015
    Report Date
    January 8, 2019
    Manufacturer
    I.T.S. GMBH
    Product Code
    HWC
    PMA / PMN Number
    K093868
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) OF THE LAST THREE SHIPMENTS OF A DISTAL FEMUR PLATE (21301-9) AND D=4.5MM CORTICAL SCREWS 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. DR. (B)(6): THE PLATE BROKE DUE TO LACK OF MEDICAL SUPPORT. SECOND SURGERY WAS 6 MONTHS LATER. THE SURGEON WAITED TOO LONG TO ACT. BETTER TREATMENT WOULD BE A MEDIAL OR VENTRAL POSITIONED PLATE AND ADDITIONAL CANCELLOUS BONE GRAFT IN THE AFFECTED AREA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DISTAL FEMUR PLATE, 9-HOLE WAS DETERMINED TO BE BENT POSTOPERATIVELY AND 4 PROXIMAL CORTICAL SCREWS BROKE. ORIGINAL IMPLANT DATE (B)(6) 2014. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015. THIS REPORT IS 2 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21317 CORTICAL SCREW, D=4.5MM CORTICAL SCREW, D=4.5MM HWC I.T.S. GMBH 32455-XX

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention