BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø2 SELF-TAP L38 TAN

    MDR report key: 3191916 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03645
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    October 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQN
    PMA / PMN Number
    K981275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. THE CONDUCTED INVESTIGATION HAS CONFIRMED THAT THE HEADER TEXT ON THE LABEL INDICATES A WRONG LENGTH. THE LABEL DOES NOT CORRESPOND WITH THE CONTENTS. THIS HAS BEEN DEEMED VALID, A CAPA DETERMINATION HAS BEEN INITIATED. THE LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS NOT YET AVAILABLE.

    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND IT WAS FOUND THAT THE LABEL IS INDEED INCORRECT. THERE ARE TWO DIFFERENT LENGTHS INDICATES ON THE LABEL. THE MAIN DESCRIPTION SHOWS L38 AND THE MULTILINGUAL SUB-DESCRIPTION L36. PLACEHOLDER.

    Description of Event or Problem · 1

    LABEL SHOWS WRONG LENGTH OF L36 INSTEAD OF L38. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293732 CORTSCR Ø2 SELF-TAP L38 TAN MQN SYNTHES GMBH 8008267

    Patients

    Seq Age Sex Outcome Treatment
    1