BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXAN IMPLANTS

    MDR report key: 1812839 · Received August 24, 2010

    Report

    Report Number
    2242816-2010-00114
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    May 3, 2010
    Report Date
    July 29, 2010
    Manufacturer
    EBI, LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL ITEMS INVOLVED IN EVENT:DESCRIPTION CATALOG NO. LOT NO. MFG. DATE1 LEVEL 10 MM PLATE 14-521110 14102S 12MM 4.0 VARIABLE SCREW 14-521612 291690 01/15/1012MM 4.0 VARIABLE SCREW 14-521612 297990 01/18/201012MM 4.0 VARIABLE SCREW 14-521612 719350 02/03/200912MM 4.5 VARIABLE SCREW 14-521642 949590 07/28/200912MM 4.0 VARIABLE SCREW 14-521512 948790 07/22/200912MM 4.5 VARIABLE SCREW 14-521544 598290 12/17/200812MM 4.5 VARIABLE SCREW 14-521542 566270 11/21/2008

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RING CAME OUT OF THE PLATE WHILE INSERTING THE SCREW. A NEW PLATE WAS IMPLANTED AND REMOVED BECAUSE THE SCREWS WERE NOT ABLE TO OBTAIN ANY BONY PURCHASE. A THIRD PLATE WAS IMPLANTED WITH NO FURTHER INCIDENTS. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXAN IMPLANTS 1 LEVEL 9MM PLATE KWQ EBI, LLC 14485S

    Patients

    Seq Age Sex Outcome Treatment
    1