BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONAL ROD BENDER-RIGHT FOR 5.5MM RODS

    MDR report key: 3071179 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-11030
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    October 1, 2012
    Report Date
    October 2, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. NO IRREGULARITIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    SYNTHES (B)(6) PRODUCT MANAGER REPORTED THAT DURING A DEMONSTRATION ON A MATRIX MODEL (NOT IN OR ON A PATIENT) THE TIP OF THE RIGHT CORONAL BENDER BROKE OFF. THE ROD ON THE MODEL IS A TITANIUM ALLOY (P/N 04.633.284) ROD. THIS SET IS PROPERTY OF MONUMENT EVALUATIONS AND WILL BE RETURNED WITH THE SET. EVENT #1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171976 CORONAL ROD BENDER-RIGHT FOR 5.5MM RODS HXW SYNTHES GMBH T945067

    Patients

    Seq Age Sex Outcome Treatment
    1