BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DMB FLEX

    MDR report key: 2634049 · Received June 22, 2012

    Report

    Report Number
    2246640-2012-00017
    Event Type
    Injury
    Date Received
    June 22, 2012
    Report Date
    May 25, 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 PROVIDED BY 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 FOR ADD'L INFO. THIS ADVERSE EVENT WAS REPORTED BY THE DENTIST AFTER OSTEOTECH SENT OUT A VOLUNTARY RECALL LETTER REQUESTING THAT PAST PT INJURIES INVOLVING RECALLED PRODUCTS BE REVIEWED. IT IS NOT KNOWN WHEN THIS REPORTED INCIDENT OCCURRED RELATIVE TO THE VOLUNTARY RECALL. 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. FINAL PRODUCT STERILITY RESULTS WERE NEGATIVE (NO GROWTH) AND ENVIRONMENTAL MONITORING RESULTS COMPLIED. DONOR SUITABILITY RECORDS WERE REVIEWED BY OSTEOTECH'S MEDICAL DIRECTOR, AND THE DONOR MET ALL ELIGIBILITY REQUIREMENTS; ALL SEROLOGY RESULTS WERE COMPLIANT. NO ADD'L REPORTS OF THIS NATURE HAVE BEEN RECEIVED BY OSTEOTECH, OR THE TISSUE RECOVERY ORGANIZATION THAT PROVIDED THE DONOR TISSUE TO OSTEOTECH, INVOLVING ANY OTHER GRAFTS FROM THIS DONOR TISSUE. BASED ON THE LACK OF PT CLINICAL INFO, OSTEOTECH'S MEDICAL DIRECTOR IS UNABLE TO CONCLUDE THAT THE PT TRULY HAD A POST-OP INFECTION. OR TO DETERMINE A DEFINITIVE CAUSE FOR THE REPORTED EVENT. HOWEVER, THERE IS NO MEDICAL EVIDENCE THAT THIS GRAFT COULD HAVE BEEN THE CAUSE OF ANY POTENTIAL POST-OP INFECTION. NO FURTHER ACTION IS REQUIRED AND THIS INCIDENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    DENTIST REPORTED THAT AFTER IMPLANTATION OF ALLOGRAFT BONE VOID FILLER, THE PT DEVELOPED "SEQUESTERED BONE." IT WAS REPORTED THAT THE PT "HAS BEEN ON ANTIBIOTICS FOR (B)(6) MONTHS AND DOES NOT APPEAR TO HAVE AN INFECTION." THE PT WAS TO BE SENT FOR A BIOPSY OF THE SITE, AND THE DENTAL OFFICE REFUSED TO PROVIDE ANY ADD'L PT INFO PENDING RESULTS OF THE BIOPSY. NO ADD'L INFO HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON DMB FLEX DEMINERALIZED BONE MATRIX ALLOGRAFT NUN OSTEOTECH, INC. 1.5 CM X 1.5 CM ATSLN0804994035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention