BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTS BIO

    MDR report key: 2834605 · Received November 15, 2012

    Report

    Report Number
    2520274-2012-03177
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    December 3, 2010
    Report Date
    December 17, 2010
    Manufacturer
    SYNTHES
    Product Code
    GXP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(4) COMPLAINT HANDLING UNIT REPORTED A NORIAN FAST SET PUTTY DISAPPEARED TWO MONTHS AFTER CRANIOPLASTY, REMOVING PART OF THE TEMPORAL BONE. THE DURA WAS NOT OPENED, BUT THE SURGEON COULD SEE THE DURA BEATING THROUGH THE SKIN. THERE WAS NO USE OF ANY OTHER PRODUCT. RADIOTHERAPY HAS BEEN USED AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTS BIO IMPLANTS BIO GXP SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention