BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGENIX DBM PUTTY

    MDR report key: 1852333 · Received September 29, 2010

    Report

    Report Number
    1030489-2010-01266
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 30, 2010
    Manufacturer
    APPTEC LABORATORY SERVICES
    Product Code
    NUN
    PMA / PMN Number
    K081950
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION. NEITHER THE DEVICE NOR (TEST RESULTS OR IMAGING FILMS) WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSED OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH DBM PUTTY DURING A CERVICAL FUSION PROCEDURE. EIGHTY-EIGHT DAYS POST-OP, THE PATIENT WAS SEEN AT THE HOSPITAL FOR AN INFECTION. THE PATIENT UNDERWENT WOUND DEBRIDEMENT, CULTURE, AND A SENSITIVITY TEST. THE TEST CAME BACK POSITIVE FOR (B)(6) INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGENIX DBM PUTTY PROGENIX DBM PUTTY NUN APPTEC LABORATORY SERVICES NA 1232010109

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention