BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM MATRIX STRIPS

    MDR report key: 2042022 · Received March 31, 2011

    Report

    Report Number
    2246640-2011-00011
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 2, 2011
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MBP
    PMA / PMN Number
    K051195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL MANUFACTURING RECORDS FOR THE SUBJECT GRAFT WERE REVIEWED, AND INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO PROCEDURE AND MET ALL SPECIFICATIONS. ALL CRITICAL PROCESSING PARAMETERS WERE MET, AND THERE WERE NO IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH THE PROCESSING OF THE PRODUCT. (B)(6) MEDICAL DIRECTOR HAS REVIEWED THE CASE AND STATES THAT THERE IS NO EVIDENCE TO INDICATE THAT THE GRAFTING MATERIAL WAS THE PROXIMATE CAUSE OF THE PATIENT'S ADVERSE REACTION. IN ADDITION, THE TREATING SURGEON STATED THAT, IN HIS OPINION, THE GRAFTING MATERIAL DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S ADVERSE REACTION. THERE HAVE BEEN NO ADDITIONAL REPORTS OF THIS NATURE ASSOCIATED WITH PRODUCTS PRODUCED FROM THIS DONOR. THIS REPORT WAS COMPLETED USING THE INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFORMATION NOT HAVING BEEN PROVIDED BY THE REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, PATIENT UNDERWENT SURGERY FOR A CERVICAL SPONDYLOTIC MYELOPATHY (STATUS POST LAMINECTOMY AND FUSION) WITH INSTRUMENTATION AND FUSION OF THE SPINE FROM C3 TO T1. DEMINERALIZED BONE GRAFTING MATERIAL WAS IMPLANTED DURING THE PROCEDURE. PATIENT WAS DISCHARGED ON (B)(6) 2011. PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2011 DUE TO SUPERFICIAL WOUND DEHISCENCE AND POSSIBLE INFECTION. ON (B)(6) 2011, PATIENT UNDERWENT SURGERY FOR AN EXPLORATION OF THE WOUND, DEBRIDEMENT AND RECLOSURE. GRAFTING MATERIAL WAS NOT EXPLANTED. PATIENT WAS PLACED ON ANTIBIOTICS (VANCOMYCIN), AND WAS DISCHARGED ON (B)(6) 2011, AT WHICH TIME HIS STATUS WAS "IMPROVING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON DBM MATRIX STRIPS DEMINERALIZED BONE MATRIX ALLOGRAFT MBP OSTEOTECH, INC. 1CM X 10CM (2 EACH) OTSCT0813114036

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R