BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGENIX DBM PUTTY

    MDR report key: 1161249 · Received September 11, 2008

    Report

    Report Number
    1030489-2008-00510
    Event Type
    Injury
    Date Received
    September 11, 2008
    Date of Event
    June 10, 2008
    Report Date
    August 13, 2008
    Manufacturer
    APPTEC LABORATORY SERVICES
    Product Code
    MBP
    PMA / PMN Number
    K072265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THE REPORTED INFECTING AGENT IS A COMMON NOSOCOMIAL CONTAMINANT, AND THIS DEVICE WAS PROVIDED STERILE. THE REPORTED EVENT IS BELIEVED TO BE A COMPLICATION ASSOCIATED WITH THE SURGICAL PROCEDURE, WHICH WAS UNRELATED TO THIS DEVICE. NEVERTHELESS, WE ARE SUBMITTING THIS MEDWATCH FOR NOTIFICATION PURPOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A DEEP SURGICAL WOUND INFECTION FOLLOWING POSTEROLATERAL LUMBAR SPINAL IMPLANTATION OF THE DEMINERALIZED BONE MATRIX PUTTY FOR TREATMENT OF SCOLIOSIS. CULTURES FOUND THAT THE COLONIZING ORGANISM WAS STAPHYLOCOCCUS AUREUS (NON-MRSA). A SURGICAL INTERVENTION WAS PERFORMED AT AN UNKNOWN TIME POST-OP IN 2008 TO IRRIGATE AND DEBRIDE THE SURGICAL WOUND. CULTURES FROM THE WOUND ALSO GREW STAPH AUREUS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention