BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 871990 · Received June 25, 2007

    Report

    Report Number
    1057129-2007-00008
    Event Type
    Injury
    Date Received
    June 25, 2007
    Report Date
    June 20, 2007
    Manufacturer
    POREX SURGICAL
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE PROVIDED ITEM NUMBERS BUT WE DID NOT RECEIVE LOT NUMBER INFORMATION. WE HAVE ATTEMPTED TO CONTACT THE DOCTOR CONCERNING PATIENT CONDITION AFTER SURGERY AND HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION. WE WERE CONTACTED BY THE PATIENT CONCERNING THE SURGERY. THE PATIENT STATED THAT THE ORIGINAL SURGEON PLACED TWO MEDPOR MALAR IMPLANTS AFTER REMOVING SILICONE IMPLANTS. THE DOCTOR HAD DIFFICULTY PLACING THE MALAR IMPLANTS DUE TO A GREAT DEAL OF SCAR TISSUE FROM YEARS OF SILICONE IMPLANTS. ACCORDING TO THE PATIENT, THE DOCTOR SECURED BOTH IMPLANTS WITH SCREWS. SHORTLY AFTER SURGERY THE PATIENT NOTICED A SHARP PROTRUDING POINT ON THE LEFT CHEEK. ONE TO TWO WEEKS AFTER SURGERY, THE PATIENT BELIEVED THAT ONE OF THE IMPLANTS HAD ROTATED AND WAS RESTING ON THE FACIAL NERVE. FIVE MONTHS AFTER SURGERY, THE DOCTOR TRIMMED THE PROTRUDING POINT OFF THE LEFT MALAR IMPLANT BY RASPING IT DOWN. THE PATIENT STATED THAT THE DOCTOR CHECKED THE RIGHT IMPLANT TO SEE IF THE IMPLANT WAS ROTATED AND INDICATED THAT THE IMPLANT WAS LOCATED WHERE IT WAS ORIGINALLY PLACED. THE PATIENT STATED THAT SHE CONSULTED ANOTHER DOCTOR TWELVE MONTHS AFTER THE SURGERY TO HAVE THE IMPLANT REMOVED. THE DOCTOR TOLD THE PATIENT THAT HE COULD NOT REMOVE THE IMPLANTS BECAUSE THEY WERE HARD AS A ROCK AND WOULD NEED TO BE CHISELED OUT. THE PATIENT WENT TO THE DOCTOR WHO CONTACTED US FOR REMOVAL INFORMATION. THE PATIENT STATED THE DOCTOR ATTEMPTED TO REMOVE THE MALAR IMPLANTS BUT COULD NOT AND INSTRUCTED HER TO GO TO THE CLINIC FOR REMOVAL. A COPY OF THE CURRENT INSTRUCTIONS FOR USE WITH CONTRAINDICATIONS LISTED IS ENCLOSED. (PLEASE SEE ADDITIONAL SCANNED PAGES).

    Description of Event or Problem · 1

    THE SURGEON STATED THAT HE HAD A PATIENT WHO RECEIVED LEFT AND RIGHT MEDPOR MALAR IMPLANTS ABOUT 16 MONTHS EARLIER IN A PROCEDURE PERFORMED BY ANOTHER SURGEON. THE MALAR IMPLANTS HAD MIGRATED AND THE SURGEON INQUIRED ABOUT THE REMOVAL PROCEDURE FOR MEDPOR IMPLANTS. HE WAS REFERRED TO A SURGEON WHO SERVES AS A CONSULTANT FOR THE COMPANY AND HAS EXPERIENCE WITH MEDPOR. POREX'S CONSULTANT REPORTED TO THE COMPANY THAT THE REPORTING SURGEON HAD TRIED TO REMOVE THE IMPLANTS BUT THEY WOULD NOT COME OUT. (SEE HIGHLIGHTED SECTION OF MEDPOR INSTRUCTION FOR USE ENCLOSED).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other