BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM PUTTY

    MDR report key: 2634045 · Received June 22, 2012

    Report

    Report Number
    2246640-2012-00016
    Event Type
    Injury
    Date Received
    June 22, 2012
    Date of Event
    April 6, 2012
    Report Date
    May 25, 2012
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MBP
    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 PROVIDED 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 AND RELEASE CRITERIA. 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, OSTEOTECH'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 AN EXTRACTION OF TOOTH #18 AND PLACEMENT OF A DENTAL IMPLANT IN #18. THE DENTIST STATED THE PT DEVELOPED A POST-OP INFECTION "IMMEDIATELY FOLLOWING PROCEDURE," AND WAS STARTED ON ANTIBIOTIC THERAPY. (B)(6) WEEKS POST-OP, THE PT CONTINUED TO BE "SWOLLEN AND UNCOMFORTABLE" AND WAS REFERRED TO AN ORAL SURGEON. THE PT'S CURRENT STATUS WAS DESCRIBED AS "HEALING WITH MODERATE BONY DEFECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON DBM PUTTY DEMINERALIZED BONE MATRIX ALLOGRAFT MBP OSTEOTECH, INC. 0.5CC OTSCT0916604092

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention