BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLIVIOS 7MM PEEK-STERILE

    MDR report key: 2112657 · Received April 29, 2011

    Report

    Report Number
    8030965-2011-00202
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 8, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PORTION OF THE IMPLANT REMAINS IN THE PT. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. MANUFACTURE DATE HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING IMPLANTATION OF THE PLIVIOS 7 MM PEEK IMPLANT, A PIECE OF THE CAGE BROKE OFF. THE BROKEN PIECE WAS RETRIEVED AND THE REST WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLIVIOS 7MM PEEK-STERILE PLIVIOS 7MM PEEK-STERILE MAX SYNTHES GMBH NA 2678184

    Patients

    Seq Age Sex Outcome Treatment
    1 NI