BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICSCR PANGEAPOLYAX Ø5 PREASSMBL L40 T

    MDR report key: 3171560 · Received June 15, 2013

    Report

    Report Number
    2530088-2013-00908
    Event Type
    Injury
    Date Received
    June 15, 2013
    Date of Event
    September 4, 2010
    Report Date
    April 13, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K103287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS NOT RETURNED AND WAS UNABLE TO BE EVALUATED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: FOUR PANGEA SCREWS WERE IMPLANTED ON (B)(6) 2009. AFTER 1.5 YEARS, TWO OF THE SCREWS BROKE (IT WAS NOT CLEAR WHICH SCREWS). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272433 PEDICSCR PANGEAPOLYAX Ø5 PREASSMBL L40 T NKB SYNTHES BRANDYWINE 5759133

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention