BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø5 SELF-TAP L75 TAN

    MDR report key: 3183578 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-03344
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    November 12, 2011
    Report Date
    March 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K962011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THERE ARE NO SHAVINGS VISIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHAVING WAS FOUND IN THE BOX. IT WAS POINTED OUT BY THE DOCTOR, WHEN VA LOCKING SCREW 2.4MM WAS TAKEN OUT FROM THE STERILIZATION BOX AND A THING LIKE SHAVING WASTE HAD ADHERED TO THE BASE OF THE LOCKING SCREW. IT WAS IMMEDIATELY EXCHANGED WITH THE LOCKING SCREW SELF-TAP L18 TAN AND COPED WITH NO PROBLEMS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284321 LOCKSCR Ø5 SELF-TAP L75 TAN HWC SYNTHES GMBH 2727725

    Patients

    Seq Age Sex Outcome Treatment
    1