BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM PUTTY

    MDR report key: 2634043 · Received June 22, 2012

    Report

    Report Number
    2246640-2012-00015
    Event Type
    Injury
    Date Received
    June 22, 2012
    Report Date
    May 24, 2012
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    NUN
    PMA / PMN Number
    K051188
    Removal / Correction Number
    2246640-042612-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH FORM WAS COMPLETED WITH THE INFO RECEIVED BY THE INITIAL REPORTER. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED BY THE INITIAL REPORTER. THIS ADVERSE EVENT WAS REPORTED BY THE DENTIST, FOLLOWING A RETROSPECTIVE REVIEW OF RELATED PT INJURIES REQUESTED BY THE COMPANY AS PART OF THE ABOVE-REFERENCED VOLUNTARY RECALL, AND WAS NOT REPORTED TO THE COMPANY AT THE TIME THE INCIDENT ORIGINALLY OCCURRED. THE MFG AND LAB TESTING RECORDS FOR THE SUBJECT GRAFT WERE REVIEWED, AND INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO PROCEDURE AND MET ALL REQUIRED SPECIFICATIONS. THERE WERE NO DEFICIENCIES, IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH THE PROCESSING OF THIS GRAFT. DONOR SUITABILITY RECORDS WERE REVIEWED BY OSTEOTECH'S MEDICAL DIRECTOR, AND THE DONOR MET ALL ELIGIBILITY REQUIREMENTS; ALL SEROLOGY RESULTS WERE COMPLIANT. THE TISSUE RECOVERY ORGANIZATION WHICH PROVIDED THE DONOR TISSUE TO OSTEOTECH, WAS NOTIFIED OF THIS INCIDENT, AND NO ADD'L REPORTS OF INFECTION HAVE BEEN RECEIVED BY THE RECOVERY ORGANIZATION, NOR BY THE OSTEOTECH INVOLVING THIS DONOR TISSUE. BASED ON THESE FINDINGS, THE COMPANY'S MEDICAL DIRECTOR HAS CONCLUDED THAT THERE IS NO MEDICAL EVIDENCE TO INDICATE THAT THIS BONE VOID FILLER WAS THE PROXIMATE CAUSE OF THE PT'S INFECTION. NO FURTHER ACTION IS REQUIRED AND THIS INCIDENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    DENTIST REPORTED THAT THE PT WAS IMPLANTED WITH ALLOGRAFT BONE VOID FILLER FOLLOWING EXTRACTION OF TOOTH #7 AND BONE AUGMENTATION IN THE SOCKET, IN COMBINATION WITH PLACEMENT OF AN ENDOSSEOUS IMPLANT. THE PT DEVELOPED A POST-OP INFECTION AND WAS GIVEN ANTIBIOTIC THERAPY. APPROXIMATELY (B)(6) MONTHS POST-OP, THE PT "HAD THE IMPLANT EXFOLIATE AFTER FAILURE TO HEAL AND INTEGRATE, AND THE PT REMOVED THE IMPLANT AT HOME." THE PT'S CURRENT STATUS WAS DESCRIBED AS "STABLE, AREA IS HEALING WITH MODERATE BONY DEFECT." THE PT WAS REFERRED TO AN ORAL SURGEON FOR FURTHER CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON DBM PUTTY DEMINERALIZED BONE MATRIX ALLOGRAFT NUN OSTEOTECH, INC. 5CC OTSCT0918694067

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention