BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHRONOS(TM) BETA-TCP WEDGE 14 DEG/RECTANGULAR-STERILE

    MDR report key: 3051844 · Received April 10, 2013

    Report

    Report Number
    8030965-2013-10858
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    October 6, 2011
    Report Date
    October 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQV
    PMA / PMN Number
    K043045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. (B)(4).

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO CORRECT A VARUS DEFORMITY TO A DISTAL TIBIA THROUGH AN OPENING WEDGE OSTEOTOMY, SURGEON PLACED THE CHRONOS BETA-TCP WEDGE, AND THE WEDGE FELL APART COMPLETELY AND COULD NOT BE USED. ACCOUNT REMOVED THE WEDGE AND DISCARDED IT. SURGEON SELECTED A FEMORAL HEAD GRAFT AND COMPLETED THE PROCEDURE.

    Description of Event or Problem · 1

    (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153475 CHRONOS(TM) BETA-TCP WEDGE 14 DEG/RECTANGULAR-STERILE MQV SYNTHES GMBH 2513922

    Patients

    Seq Age Sex Outcome Treatment
    1