BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD

    MDR report key: 2713268 · Received August 17, 2012

    Report

    Report Number
    2520274-2012-01627
    Event Type
    Malfunction
    Date Received
    August 17, 2012
    Report Date
    July 20, 2012
    Product Code
    EZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: A FEMALE PT EXPERIENCED A COMMINUTED FRACTURE OF TH12 DUE TO OSTEOPOROSIS. CONSERVATIVE TREATMENT WAS GIVEN WITH 3 POINT ORTHOSIS. THE KYPHOSIS ANGLE CHANGED FROM 6 TO 16 GRADE WITH OPERATIVE TREATMENT FOLLOWING, DATE OF SURGERY UNK. PT WAS TREATED WITH DORSAL STABILIZATION TH11 - L1 AND KYPHOPLASTY ON TH12 BE MEANS OF USS FRACTURE MIS HARDWARE. IT WAS NOTED AFTER THE SURGERY THERE WAS A MINIMAL LOSS OF HEIGHT. THE HARDWARE HAS NOT BEEN EXPLANTED AND THERE ARE NO PLANS TO REMOVE THE HARDWARE. NO FURTHER INFO IS AVAILABLE. THIS IS 14 OF 14 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROD EZP

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR