BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM PUTTY

    MDR report key: 2634051 · Received June 22, 2012

    Report

    Report Number
    2246640-2012-00018
    Event Type
    Injury
    Date Received
    June 22, 2012
    Date of Event
    March 8, 2012
    Report Date
    May 25, 2012
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MBP
    PMA / PMN Number
    K051195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH FORM WAS COMPLETED WITH THE INFO PROVIDED BY THE INITIAL REPORTER. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED BY THE INITIAL REPORTER. NO REVIEW OF MFG RECORDS FOR THE SUBJECT GRAFT WAS POSSIBLE WITHOUT ADD'L DEVICE INFO. NO X-RAYS OR IMAGING STUDIES WERE PROVIDED. WE ARE THEREFORE, UNABLE TO DETERMINE A DEFINITIVE CAUSE FOR THE REPORTED EVENT. NO FURTHER ACTION IS REQUIRED, AND THIS INCIDENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    PODIATRIST REPORTED THAT HE IMPLANTED BONE VOID FILLER GRAFT IN A PT DURING AN ANKLE JOINT PROCEDURE AND THE PT DEVELOPED A NON-UNION. DATE OF ORIGINAL SURGERY WAS NOT REPORTED. IT WAS REPORTED THAT THE DR USED A BONE STIMULATOR AND PLACED THE PT IN AN EXTERNAL FIXATOR IMMEDIATELY FOLLOWING THE PROCEDURE. NO ADD'L PT OR CLINICAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON DBM PUTTY DEMINERALIZED BONE MATRIX ALLOGRAFT MBP OSTEOTECH, INC. NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention