BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXAN ANTERIOR PLATING SYSTEM

    MDR report key: 2048825 · Received April 11, 2011

    Report

    Report Number
    2242816-2011-00033
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    EBI, LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG/LOT NUMBERS - 4.0 VARIABLE SCREW - 14-521614/221550, 4.0 VARIABLE SCREW - 14-521614/598080, 4.0 VARIABLE SCREW - 14-521614/336970, 4.0 VARIABLE SCREW - 14-521614/835180, 4.0 VARIABLE SCREW - 14-521614/566040.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RING ON THE PLATE HAD ROTATED AND SEPARATED FROM THE PLATE. PATIENT OUTCOME: THE REPORT INDICATES THAT THE PATIENT HAD A SUCCESSFUL SURGERY. NO ADVERSE EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXAN ANTERIOR PLATING SYSTEM TWO LEVEL 30MM PLATE KWQ EBI, LLC 13273J

    Patients

    Seq Age Sex Outcome Treatment
    1