BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM PUTTY

    MDR report key: 2964341 · Received February 15, 2013

    Report

    Report Number
    2246640-2013-00004
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    July 10, 2012
    Report Date
    January 8, 2013
    Manufacturer
    OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)
    Product Code
    NUN
    PMA / PMN Number
    K051188
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS MEDWATCH REPORT WAS COMPLETED USING THE INFORMATION PROVIDED BY THE INITIAL REPORTER/HEALTHCARE PROFESSIONAL. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFORMATION NOT HAVING BEEN PROVIDED BY THE REPORTER. NEITHER THE DEVICE NOR IMAGING FILMS WERE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY NONCONFORMANCES TO SPECIFICATION. IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT; THIS REPORT IS BEING SUBMITTED FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HAD BONE VOID FILLER IMPLANTED DURING AN UNKNOWN DENTAL PROCEDURE. AFTER AN UNSPECIFIED PERIOD OF TIME, "THE GINGIVA DISINTEGRATED" AND THE DENTIST PERFORMED A "REVISION" ON THE PATIENT AND NEEDED TO "DEBRIDE, IRRIGATE AND TAKE A GRAFT FROM THE HIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68634 GRAFTON DBM PUTTY BONE GRAFTING MATERIAL, HUMAN SOURCE NUN OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) OTSCT1019084075

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention