BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM PUTTY

    MDR report key: 2624431 · Received June 14, 2012

    Report

    Report Number
    2246640-2012-00012
    Event Type
    Injury
    Date Received
    June 14, 2012
    Date of Event
    January 1, 2012
    Report Date
    May 15, 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
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH FORM WAS COMPLETED WITH THE INFO RECEIVED FROM THE INITIAL REPORTER. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED BY THE INITIAL REPORTER DESPITE MULTIPLE REQUESTS BY THE COMPANY. THIS ADVERSE EVENT WAS REPORTED BY THE DENTIST FOLLOWING A RETROSPECTIVE REVIEW OF RELATED PT INJURIES REQUESTED BY THE COMPANY, AS PART OF THE RECALL, AND 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. THERE WERE NO DEFICIENCIES, IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH THE PROCESSING OF THIS GRAFT. DONOR SUITABILITY RECORDS WERE REVIEWED AND THE DONOR MET ALL ELIGIBILITY REQUIREMENTS. THE TISSUE RECOVERY ORGANIZATION WHICH PROVIDED THE DONOR TISSUE TO THE COMPANY WAS NOTIFIED OF THIS INCIDENT, AND NO ADDITIONAL REPORTS OF INFECTION HAVE BEEN RECEIVED BY THE COMPANY, OR THE RECOVERY ORGANIZATION, INVOLVING THIS DONOR TISSUE. BASED ON THESE FINDINGS, THE COMPANY'S (B)(4) HAS CONCLUDED THAT THERE IS NO MEDICAL EVIDENCE TO INDICATE THAT THE GRAFT 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 ON A CUSTOMER REPLY FORM THAT A PT HAD DEVELOPED A POST-OPERATIVE INFECTION AND "LOSS OF (DENTAL) IMPLANT" FOLLOWING IMPLANTATION OF ALLOGRAFT BONE VOID FILLER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFO FROM THE DENTIST ABOUT THE PT'S MEDICAL STATUS, BUT NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON DBM PUTTY DEMINERALIZED BONE MATRIX ALLOGRAFT NUN OSTEOTECH, INC. 2.5CC OTSCT0823854035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention