BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL HUMERAL PLATE, 4-HOLE

    MDR report key: 8230385 · Received January 9, 2019

    Report

    Report Number
    3004369035-2016-00006
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    May 23, 2016
    Report Date
    January 9, 2019
    Manufacturer
    I.T.S. GMBH
    Product Code
    HRS
    UDI-DI
    09120047297353
    PMA / PMN Number
    K051412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) OF THE LAST THREE SHIPMENTS OF THE PLATE 21133-4 AND THE RESP. SCREWS THAT WERE SEND TO (B)(6) 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 PROXIMAL PLATE HOLES SHOWED ONLY MINOR DEFORMATION. THUS THE LOCKING SCREWS WERE NOT FULLY ENGAGED IN THE PLATE. FURTHERMORE, THE SCREWS BACKED OUT DUE TO NON-UNION OF THE HUMERAL FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCREWS BACKED OUT OF A PROXIMAL HUMERAL PLATE, 4-HOLE POSTOPERATIVELY. ORIGINAL IMPLANT DATE (B)(6) 2016. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24892 PROXIMAL HUMERAL PLATE, 4-HOLE PROXIMAL HUMERAL PLATE, 4-HOLE HRS I.T.S. GMBH 21133-4 09120047297353

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention