BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM

    MDR report key: 3932677 · Received July 14, 2014

    Report

    Report Number
    2246640-2014-00008
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 23, 2014
    Manufacturer
    OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC)
    Product Code
    MBP
    PMA / PMN Number
    K051195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR ANY PATIENT MEDICAL RECORDS OR IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PART NUMBER OR LOT INFORMATION WAS PROVIDED; THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORDS WAS POSSIBLE. THE MANUFACTURER IS UNABLE TO EVALUATE OR DETERMINE A DEFINITIVE CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON HAD STOPPED USING THE ALLOGRAFT BONE VOID FILLER PRODUCT AS A RESULT OF 'DRAINING ISSUES' WHICH HE IS ATTRIBUTING TO THE PRODUCT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, THOUGH NONE WAS PROVIDED. IT IS NOT KNOWN WHETHER ANY MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409075 GRAFTON DBM FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) MBP OSTEOTECH, INC (SUBSIDIARY OF MEDTRONIC) NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other