BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNIFUSE (GRAFTON II EDEM)

    MDR report key: 2447606 · Received February 8, 2012

    Report

    Report Number
    2246640-2012-00002
    Event Type
    Injury
    Date Received
    February 8, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQV
    PMA / PMN Number
    K082615
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH FORM WAS COMPLETED WITH THE INFORMATION PROVIDED BY THE INITIAL REPORTER. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFORMATION NOT HAVING BEEN PROVIDED. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE BY OSTEOTECH TO OBTAIN ADDITIONAL DETAILS REGARDING THE PT'S TREATMENT AND PROGRESS. THE MANUFACTURING RECORDS FOR THE SUBJECT GRAFT WERE REVIEWED AND INDICATED THAT THE GRAFT WAS MANUFACTURED PER PROCEDURE AND MET ALL SPECIFICATIONS AND RELEASE CRITERIA. ALL CRITICAL PROCESSING PARAMETERS WERE MET DURING THE PROCESSING OF THE SUBJECT LOT OF PRODUCT. THERE WERE NO REPORTED DEVIATIONS, IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH MANUFACTURING. FINAL PRODUCT STERILITY RESULTS WERE NEGATIVE (NO GROWTH), AND ENVIRONMENTAL MONITORING RESULTS WERE ACCEPTABLE. A COMPREHENSIVE REVIEW OF THE DONOR RECORDS BY OSTEOTECH'S MEDICAL DIRECTOR CONCLUDED THAT THE SUBJECT DONOR HAD BEEN APPROPRIATELY SCREENED AND TESTED IN ACCORDANCE WITH OSTEOTECH'S DONOR SUITABILITY CRITERIA. THE TISSUE RECOVERY ORGANIZATION WHICH PROVIDED THE DONOR TISSUE TO OSTEOTECH ((B)(4)) WAS NOTIFIED OF THIS REPORT; NEITHER THEY, NOR OSTEOTECH, HAS RECEIVED ANY ADDITIONAL REPORTS OF INFECTION INVOLVING TISSUES PROCURED, OR PRODUCTS MANUFACTURED FROM THE SUBJECT DONOR. BASED ON THESE FINDINGS AND THE LIMITED MEDICAL INFORMATION PROVIDED, OSTEOTECH'S (B)(4) HAS FOUND NO EVIDENCE LINKING THE RECIPIENT'S CONDITION WITH THE IMPLANTED GRAFT. NO FURTHER ACTION IS REQUIRED AND THIS INVESTIGATION IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE PT RECEIVED A BONE VOID FILLER ALLOGRAFT, AND APPROXIMATELY TWO WEEKS LATER DEVELOPED A POST-OPERATIVE INFECTION. AT THAT TIME, THE PT WAS REPORTEDLY PUT ON ANTIBIOTICS, BROUGHT BACK FOR AN "I&D" OF THE POSTERIOR CERVICAL WOUND AND THE GRAFT MATERIAL WAS REMOVED. TWO DAYS AFTER THIS INITIAL REVISION, THE PT WAS BROUGHT BACK FOR AN "I&D" OF AN ANTERIOR CERVICAL ABSCESS, AND UNDER EVALUATION IS IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNIFUSE (GRAFTON II EDEM) DEMINERALIZED BONE MATRIX ALLOGRAFT MQV OSTEOTECH, INC. OTSCT0824761474

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R