BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGENIX DBM PUTTY

    MDR report key: 2001843 · Received February 25, 2011

    Report

    Report Number
    1030489-2011-00207
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 28, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MQV
    PMA / PMN Number
    K060794
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OSTEOTOMY AT TOOTH #7 WHERE DBM PUTTY WAS PLACED IN AN OSTEOTOMY SITE. DURING A ROUTINE POST-OP FOLLOW UP, THE PATIENT REPORTED HAVING PAIN AT THE IMPLANT SITE. THE GRAFT WAS REMOVED 22 DAYS POST-OP DUE TO IMPLANT MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGENIX DBM PUTTY FILLER, BONE VOID, CALCIUM COMPOUND MQV MEDTRONIC SOFAMOR DANEK 1394570003

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention