BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CURVED RECONSTRUCTION PLATE 8 HOLES

    MDR report key: 3115196 · Received May 16, 2013

    Report

    Report Number
    3003506883-2013-00225
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTW
    PMA / PMN Number
    K792291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PART NUMBER 245.31 MADE ON WORK ORDER (B)(4) AND LOT NUMBER 6860227 HAD NO NCRS. MATERIAL LOT 6293615 FROM WHICH THESE PARTS WERE MADE NO NCRS AND CERTIFICATES WERE FOUND TO BE IN ORDER. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PATIENT UNDERWENT ACETABULUM SURGERY. PLATE AND SCREWS WERE IMPLANTED. ON (B)(6) 2013, THE PATIENT REQUIRED REVISION SURGERY FOR REPLACEMENT SCREWS. IT WAS REPORTED THAT THE PATIENT HAD BEEN INVOLVED IN A MOTOR VEHICLE ACCIDENT. THE ORIGINAL PLATE AND SCREWS WERE REMOVED AND A 7.3MM CANNULATED, 55MM CORTICAL, AND 50MM CORTICAL SCREWS WERE IMPLANTED. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217736 3.5MM CURVED RECONSTRUCTION PLATE 8 HOLES KTW SYNTHES ELMIRA 6860227

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention