BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 857508 · Received May 29, 2007

    Report

    Report Number
    1057129-2007-00009
    Event Type
    Injury
    Date Received
    May 29, 2007
    Date of Event
    April 17, 2007
    Report Date
    May 24, 2007
    Manufacturer
    POREX SURGICAL
    Product Code
    JAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE PAST TWO YEARS, WE MANUFACTURED 1593 PIECES AND DISTRIBUTED 1483 PIECES OF THE EAR RIM IMPLANTS. OF THE 1483 PIECES DISTRIBUTED, THE COMPLAINT PERCENTAGE RATE FOR THE PAST TWO YRS IS .0026. WE HAVE HAD THREE OTHER INCIDENCES CONCERNING EXPOSED EAR RIM IMPLANTS. THE MDR REPORTING #'S ARE 1057129-2006-0014, 1057129-2007-0001 AND 1057129-2007-0008. A COPY OF THE CURRENT INSTRUCTIONS FOR USE IS ENCLOSED.

    Description of Event or Problem · 1

    THE DR PLACED TWO MEDPOR EAR IMPLANTS (EAR RIM AND BASE) IN 2006. THE MEDPOR EAR RIM IMPLANT BECAME EXPOSED BY THE FIRST MO. THE DR REPAIRED THE EXPOSED AREA OF THE IMPLANT BUT IN 2007, THE DR STATED, THAT SHE REMOVED THE EAR RIM IMPLANT. THE DR STATED, THAT SHE DID NOT USE THE CORRECT TECHNIQUE AND THAT THE PT DID NOT FOLLOW THE POST-OP INSTRUCTIONS. THE DR STATED, THAT WITH THE HELP OF ANOTHER SURGEON FAMILIAR WITH THE TECHNIQUE, SHE WOULD REPLACE THE EAR RIM IMPLANT AT ANOTHER DATE. THE PT IS DOING WELL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT FACIAL RECONSTRUCTION JAZ POREX SURGICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other