BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM PUTTY

    MDR report key: 2589893 · Received May 22, 2012

    Report

    Report Number
    2246640-2012-00007
    Event Type
    Injury
    Date Received
    May 22, 2012
    Date of Event
    August 15, 2011
    Report Date
    April 23, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ADVERSE EVENT WAS REPORTED BY THE HOSPITAL FOLLOWING A RETROSPECTIVE REVIEW OF RELATED PATIENT INJURIES REQUESTED BY THE COMPANY AS PART OF THE 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. THE DONOR TISSUE WAS PRE-TREATED WITH GAMMA IRRADIATION PRIOR TO PROCESSING. THERE WERE NO DEFICIENCIES, IRREGULARITIES OR NON-CONFORMANCE 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 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

    APPROXIMATELY 4 WEEKS AFTER RECEIVING BONE VOID FILLER DURING A REPAIR OF A RIGHT CLAVICLE FRACTURE, THE PATIENT PRESENTED WITH WOUND DRAINAGE. PATIENT WAS PLACED ON ORAL ANTIBIOTICS AND READMITTED TO THE HOSPITAL 9 DAYS LATER FOR IRRIGATION AND DEBRIDEMENT, AND REMOVAL OF THE HARDWARE AND GRAFT MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON DBM PUTTY DEMINERALIZED BONE MATRIX ALLOGRAFT NUN OSTEOTECH, INC. 1CC OTSM00787784106

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R HARDWARE