BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM PUTTY, 1.0CC

    MDR report key: 2634032 · Received June 26, 2012

    Report

    Report Number
    2246640-2012-00020
    Event Type
    Injury
    Date Received
    June 26, 2012
    Report Date
    May 30, 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 Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH FORM WAS COMPLETED WITH THE INFORMATION RECEIVED FROM THE INITIAL REPORTER. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFORMATION NOT HAVING BEEN PROVIDED BY THE INITIAL REPORTER. THIS ADVERSE EVENT WAS REPORTED BY THE DENTIST FOLLOWING A RETROSPECTIVE REVIEW OF RELATED PATIENT INJURIES REQUESTED BY OSTEOTECH/MEDTRONIC AS PART OF THE ABOVE-REFERENCED VOLUNTARY RECALL. THE EVENT WAS NOT REPORTED TO THE COMPANY AT THE TIME THE INCIDENT ORIGINALLY OCCURRED. THE MANUFACTURING AND LABORATORY 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 AND THE DONOR WAS CONFIRMED TO HAVE MET ALL ELIGIBILITY REQUIREMENTS. THE DONOR TISSUE WAS IRRADIATED, WITHIN THE REQUIRED DOSE RANGE, PRIOR TO PROCESSING. THE TISSUE RECOVERY ORGANIZATION WHICH PROVIDED THE DONOR TISSUE TO OSTEOTECH WAS NOTIFIED OF THIS INCIDENT, AND NO ADDITIONAL REPORTS OF INFECTION HAVE BEEN RECEIVED BY THE RECOVERY ORGANIZATION, OR BY OSTEOTECH, INVOLVING THIS DONOR TISSUE. BASED ON THESE FINDINGS, THE OSTEOTECH'S MEDICAL DIRECTOR HAS CONCLUDED THAT THERE IS NO MEDICAL EVIDENCE TO INDICATE THAT THE GRAFT WAS THE PROXIMATE CAUSE OF THE PATIENT'S INFECTION. NO FURTHER ACTION IS REQUIRED, AND THIS INCIDENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    DENTIST REPORTED ON A CUSTOMER REPLY FORM THAT A PATIENT RECEIVED ALLOGRAFT BONE VOID FILLER DURING A BONE AUGMENTATION PROCEDURE, AND DEVELOPED A POST-OP INFECTION "WHICH RESOLVED UNEVENTFULLY BUT LED TO COMPLETE LOSS OF GRAFT." MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITION PATIENT INFORMATION, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON DBM PUTTY, 1.0CC DEMINERALIZED BONE MATRIX ALLOGRAFT NUN OSTEOTECH, INC. OTSCT0906634104

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention