BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø3.5 SELF-TAP L34 SST

    MDR report key: 3192930 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03590
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    February 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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). A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. THE INVESTIGATION HAS SHOWN THAT IT CONCERNS A PACKAGING FAULT DURING WHICH A WRONG ARTICLE WAS PACKED. THIS WAS FOUND TO BE A MANUFACTURING ISSUE. A CAPA DETERMINATION REQUEST HAS BEEN INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WRONG ARTICLE WAS INSIDE THE PACKAGE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292263 LOCKSCR Ø3.5 SELF-TAP L34 SST KTT SYNTHES GMBH 3307905

    Patients

    Seq Age Sex Outcome Treatment
    1