BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGENIX DBM PUTTY

    MDR report key: 2061289 · Received April 18, 2011

    Report

    Report Number
    1030489-2011-00436
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    July 19, 2010
    Report Date
    March 22, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MQV
    PMA / PMN Number
    K060794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 A DENTAL IMPLANT PLACEMENT AT TOOTH #9 WITH 0.5 CC OF DBM PUTTY PLACED AROUND THE IMPLANT. THE PATIENT CAME BACK TO THE PHYSICIAN'S OFFICE 246 DAYS POST-OP AND COMPLAINED OF PAIN IN THE PALATE AND A BODY RASH ON HER BODY THAT STARTED 3 HOURS AFTER IMPLANTATION AND HASN'T STOPPED. THE SURGEON SUSPECTS POSSIBLE NERVE DAMAGE AND/OR ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGENIX DBM PUTTY FILLER, BONE VOID, CALCIUM COMPOUND MQV MEDTRONIC SOFAMOR DANEK 1349790004

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention