BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON (DEMINERALIZED BONE MATRIX) DBM

    MDR report key: 2624594 · Received June 13, 2012

    Report

    Report Number
    2246640-2012-00008
    Event Type
    Injury
    Date Received
    June 13, 2012
    Date of Event
    January 1, 2012
    Report Date
    May 14, 2012
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQV
    PMA / PMN Number
    K051195
    Removal / Correction Number
    2246640-042612-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ADVERSE EVENT WAS REPORTED BY THE HOSPITAL FOLLOWING A RETROSPECTIVE REVIEW OF RELATED PT INJURIES REQUESTED BY MEDTRONIC AS PART OF THE RECALL. THIS EVENT WAS NOT REPORTED TO THE COMPANY AT THE TIME THE INCIDENT ORIGINALLY OCCURRED. NO REVIEW OF THE APPLICABLE MANUFACTURING AND DONOR TISSUE RECORDS FOR THE IMPLANTED PRODUCT WAS POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. BASED ON THIS INFORMATION, WE ARE UNABLE TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, HOWEVER WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. NO FURTHER ACTION IS REQUIRED, AND THIS INCIDENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    HOSPITAL NOTIFIED THE COMPANY THAT A PT HAD DEVELOPED A POST-OPERATIVE INFECTION FOLLOWING IMPLANTATION OF "RECALLED" ALLOGRAFT BONE VOID FILLER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE HOSPITAL ABOUT THE PT'S MEDICAL STATUS AND THE PRODUCT IMPLANTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON (DEMINERALIZED BONE MATRIX) DBM DEMINERALIZED BONE MATRIX ALLOGRAFT MQV OSTEOTECH, INC. NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention