BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORM TERINO MALAR SHELL IMPLANT, SMALL

    MDR report key: 2890543 · Received December 20, 2012

    Report

    Report Number
    2028924-2012-00007
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 26, 2012
    Report Date
    December 20, 2012
    Manufacturer
    IMPLANTECH ASSOCIATES INC.
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: REVIEWED DEVICE HISTORY RECORDS, STERILIZATION RECORDS, AND PRODUCT LABELING. DEVICE HISTORY RECORD REVIEW REVEALED NO ASSIGNABLE CAUSE FOR THE REPORTED EVENT. PRODUCT LABELING ADDRESSES THE POSSIBILITY OF INFECTION.

    Description of Event or Problem · 1

    THE COMPLAINANT PHYSICIAN REPORTED THAT PT WAS IMPLANTED WITH MALAR IMPLANTS AND SUBSEQUENTLY HAD DEVICES EXPLANTED BILATERALLY DUE TO INFECTION. PRIOR TO EXPLANT, BOTH SIDES WERE DRAINED ON SEVERAL OCCASIONS. NO CULTURE WAS TAKEN, SO NO ORGANISM HAS BEEN IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFORM TERINO MALAR SHELL IMPLANT, SMALL MALAR IMPLANT LZK IMPLANTECH ASSOCIATES INC. NA 845065

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention