BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTATIC BONE PUTTY STERILE

    MDR report key: 3021498 · Received March 26, 2013

    Report

    Report Number
    1719045-2013-10431
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    April 26, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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. DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND SHOWED THAT THERE WERE TWO NON-CONFORMANCES FOR THIS LOT. SINCE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, IT CANNOT BE DETERMINED IF THE NON-CONFORMANCES ARE RELEVANT TO THE COMPLAINT CONDITION. THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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 VETERINARY HEMOSTATIC BONE PUTTY WAS USED IN A VENTRAL SLOT. THE PRODUCT DID NOT STICK AND WAS NOT PUTTY ENOUGH. THERE SEEMED TO BE AN ISSUE WITH SPREADING THE PUTTY AND HAVING IT STAY IN PLACE. THE SURGEON ALSO HAD ISSUE WITH IT STOPPING THE BLEEDING. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123127 HEMOSTATIC BONE PUTTY STERILE MQV SYNTHES MONUMENT 6711104

    Patients

    Seq Age Sex Outcome Treatment
    1