BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL HUMERAL PLATE, 4-HOLE

    MDR report key: 8225699 · Received January 8, 2019

    Report

    Report Number
    3004369035-2014-00006
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Report Date
    January 8, 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
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) OF THE LAST THREE SHIPMENTS TO (B)(6) OF THE PLATE 21133-4 AND THE RESP. SCREWS 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 HAVE CONSULTED AN EXPERIENCED TRAUMA SURGEON FOR HIS INDEPENDENT OPINION: (B)(6): THE X-RAY SHOWS A SUBCAPITAL FRACTURE THAT WAS NOT REDUCED IN GOOD WAY. THIS LED TO A PSEUDOARTHROSIS AND SUBSEQUENT TO A FATIGUE FRACTURE OF THE IMPLANT. FURTHERMORE, THE PLATE IS NOT INDICATED FOR SUBCAPITAL HUMERAL FRACTURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCREWS BACKED OUT OF A PROXIMAL HUMERAL PLATE, 4-HOLE POSTOPERATIVELY. ORIGINAL IMPLANT DATE IN (B)(6) 2014. A REVISION SURGERY WAS PERFORMED ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19238 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 41 YR Required Intervention