BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW LOCKING

    MDR report key: 2842703 · Received November 21, 2012

    Report

    Report Number
    2520274-2012-03315
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 26, 2012
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT. 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

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PERIPROSTHETIC FRACTURE PROCEDURE THE SURGEON COULD NOT SCREW INTO THE PLATE WITH THE FOLLOWING: DRILL GUIDE, LOCKING SCREW AND CERCLAGE. SURGEON DID IMPLANT THE PLATE USING CORTEX SCREWS AND COMPLETED THE PROCEDURE. THIS IS 3 OF 4 REPORTS FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW LOCKING HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 DRILL GUIDE, LOCKING SCREW, AND CERCLAGE.