BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORIAN® SRS® BONE VOID FILLER ROTARY MIX 5CC-STERILE

    MDR report key: 3083448 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-11157
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 10, 2012
    Report Date
    July 10, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    MQV
    PMA / PMN Number
    K060408
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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 FILL A CYST ON THE DISTAL TIBIA, WITH THE NORIAN PRODUCT. THE SURGEON FOLLOWED THE PROTOCOL FOR MIXING THE NORIAN; INJECTING THE SOLUTION INTO THE POWDER, ROLL-OUT AND ADDING TO THE INJECTION TUBE HOWEVER, AT THE POINT OF TRYING TO ADD THE PRODUCT TO THE INJECTION TUBE, THE SURGEON FOUND THAT THE PRODUCT HAD ALREADY BEGUN TO HARDEN AND WAS UNUSABLE. THE SURGEON MIXED NEW PRODUCT AND WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT AND WITH NO ADVERSE EFFECT TO THE PATIENT NOTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185719 NORIAN® SRS® BONE VOID FILLER ROTARY MIX 5CC-STERILE MQV SYNTHES USA N002829

    Patients

    Seq Age Sex Outcome Treatment
    1