BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON PLUS DBM PASTE

    MDR report key: 2651999 · Received June 21, 2012

    Report

    Report Number
    2246640-2012-00019
    Event Type
    Injury
    Date Received
    June 21, 2012
    Date of Event
    September 13, 2011
    Report Date
    May 23, 2012
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MBP
    PMA / PMN Number
    K043048
    Removal / Correction Number
    2246640-042612-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH FORM WAS COMPLETED USING THE INFO PROVIDED ON THE MAUDE EVENT REPORT RECEIVED FROM CDRH. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED ON THE REPORT. THE INITIAL REPORTER WAS NOT IDENTIFIED, THEREFORE NO ADD'L INFO COULD BE OBTAINED BY OSTEOTECH. THIS INCIDENT WAS REPORTED AFTER A VOLUNTARY RECALL LETTER, REQUESTING THAT HOSPITALS REVIEW PAST PT INJURIES INVOLVING RECALLED PRODUCT, WAS SENT OUT BY MEDTRONIC/OSTEOTECH. THIS INCIDENT WAS NOT REPORTED AT THE TIME THE INCIDENT ORIGINALLY OCCURRED. OSTEOTECH'S MEDICAL DIRECTOR HAS CONFIRMED THAT THE SUBJECT DONOR WAS APPROPRIATELY SCREENED AND TESTED IN ACCORDANCE WITH DONOR SUITABILITY CRITERIA. ALL SEROLOGY RESULTS COMPLIED. MFG RECORDS WERE REVIEWED AND INDICATED THAT THE SUBJECT GRAFT WAS MANUFACTURED PER PROCEDURE AND MET ALL SPECS AND RELEASE CRITERIA. ALL CRITICAL PROCESSING PARAMETERS WERE MET DURING THE PROCESSING OF THE PRODUCT, AND THERE WERE NO DEVIATIONS, IRREGULARITIES OR NON-CONFORMANCES ASSOCIATED WITH MFG. FINAL PRODUCT STERILITY RESULTS WERE NEGATIVE (NO GROWTH), AND ENVIRONMENTAL MONITORING RESULTS COMPLIED. NO ADD'L REPORTS OF INFECTION HAVE BEEN RECEIVED BY OSTEOTECH INVOLVING THIS DONOR TISSUE, NOR BY THE TISSUE RECOVERY ORGANIZATION WHICH PROVIDED THE TISSUE TO OSTEOTECH. OSTEOTECH'S MEDICAL RECORD DIRECTOR HAS OCCLUDED THAT THERE IS NO MEDICAL EVIDENCE LINKING THE GRAFT TO THE PT'S INFECTION. NO FURTHER ACTION IS REQUIRED, AND THIS INCIDENT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA VOLUNTARY MEDWATCH THAT A PT HAD DEVELOPED A SURGICAL SITE INFECTION TWO DAYS AFTER IMPLANTATION WITH AN ALLOGRAFT BONE VOID FILLER. THE PT REQUIRED A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTON PLUS DBM PASTE DEMINERALIZED BONE MATRIX ALLOGRAFT MBP OSTEOTECH, INC. OTSCT0906534096

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention