BEUDAMED
    FDA Adverse Event Summary report: N

    NONE

    MDR report key: 2212492 · Received August 9, 2011

    Report

    Report Number
    3002600221-2011-00001
    Date Received
    August 9, 2011
    Date of Event
    January 4, 2010
    Report Date
    July 13, 2011
    Product Code
    MBP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH FORM WAS COMPLETED WITH THE INFO RECEIVED BY THE REPORTER. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED BY THE REPORTER. SINCE RECEIVING THE INITIAL INCIDENT REPORT ON (B)(6) 2011, OSTEOTECH MADE MULTIPLE ATTEMPTS TO OBTAIN THE PRODUCT AND LOT INFO FROM THE INITIAL REPORTER PRIOR TO SUBMITTING THIS MEDWATCH REPORT. AS THE NECESSARY INFO WAS ONLY RECEIVED BY OSTEOTECH ON THE DAY THIS REPORT WAS FILED ((B)(4)), NO REVIEW OF THE APPLICABLE BATCH PROCESSING RECORDS WAS POSSIBLE PRIOR TO THE FILING OF THIS MEDWATCH REPORT. OSTEOTECH HAS INITIATED THE REVIEW OF THE APPLICABLE MANUFACTURING RECORDS. THE CASE WILL BE REVIEWED BY OSTEOTECH'S MEDICAL DIRECTOR, AND A FOLLOW-UP REPORT OF FINDINGS WILL BE SUBMITTED UPON COMPLETION OF THE REVIEW. NO ADDITIONAL REPORTS OF INFECTION HAVE BEEN RECEIVED INVOLVING ANY OTHER GRAFTS MANUFACTURED FROM THIS DONOR TISSUE. THE TISSUE RECOVERY ORGANIZATION WHICH PROVIDED THE DONOR TISSUE TO OSTEOTECH, AND WHICH ALSO DETERMINED THE DONOR'S ELIGIBILITY FOR TRANSPLANTATION, HAS BEEN NOTIFIED OF THIS ADVERSE EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY (B)(6) (ON (B)(6) 2011), THE SUBJECT GRAFT WAS IMPLANTED ON (B)(6) 2010 DURING A LUMBAR DECOMPRESSION AND FUSION PROCEDURE. AT FOLLOW-UP, ON (B)(6) 2011, PT PRESENTED WITH PUS OOZING FROM THE INCISION. PT WAS RE-HOSPITALIZED ON (B)(6) 2011, AND UNDERWENT IRRIGATION/DEBRIDEMENT AND REMOVAL OF PLATES AND SCREWS. IT IS UNK IF THE SUBJECT BONE GRAFT WAS EXPLANTED. PT WAS REPORTED AS STABLE, AND CONTINUING ON ANTIBIOTICS, AS OF (B)(6) 2011. LANX SPINAL HARDWARE (SPECIFIC PART #S UNK) IMPLANTED DURING SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE MBP

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O| R XPANSE R BONE INSERT (DEMINERALIZED| ALLOGRAFT BONE)