BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2852755 · Received November 30, 2012

    Report

    Report Number
    1030489-2012-02511
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    September 5, 2012
    Report Date
    October 31, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATIONS: MESFIN ET AL. HIGH-DOSE RHBMP-2 FOR ADULTS: MAJOR AND MINOR COMPLICATIONS. A STUDY OF 502 SPINE CASES. JOURNAL OF BONE <(>&<)> JOINT SURGERY. 2013 2013;95:1546-53; MESFIN A ET AL. DIBOTERMIN-: CANCER AND RADICULOPATHY: 18 CASE REPORTS. REACTIONS WEEKLY; 1532, P79. 20 DEC 2014.

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: MESFIN ET AL. HIGH DOSE BMP-2 IN ADULTS: MAJOR AND MINOR COMPLICATIONS IN 502 CASES. SCOLIOSIS RESEARCH SOCIETY, 47TH ANNUAL MEETING <(>&<)> COURSE (2012). AVERAGE AGE 52.4 YRS (RANGE 18-80 YRS). PT SEX: 410 FEMALES, 92 MALES. DATES OF IMPLANT: 2002-2009. (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    OF THE SEVENTEEN PATIENTS WHO DEVELOPED A TUMOR, WHICH WAS MALIGNANT IN SIXTEEN AND NONCANCEROUS (AN ACOUSTIC NEUROMA) IN ONE, THE AVERAGE RHBMP-2 DOSE WAS 91 MG (RANGE, 48 TO 300 MG) AND THE AVERAGE DURATION OF FOLLOW-UP WAS FORTY-EIGHT MONTHS (RANGE, FOURTEEN TO EIGHTY MONTHS). THE SIXTEEN CASES OF MALIGNANT DISEASE INCLUDED BREAST CANCER IN EIGHT PATIENTS (ONE PATIENT DIED AT FOURTEEN MONTHS POSTOPERATIVELY FROM METASTATIC DISEASE), RENAL CELL CANCER IN TWO, AND BLADDER CANCER, OVARIAN CANCER, LOWER-EXTREMITY SARCOMA, COLON CANCER, LUNG CANCER, AND NONINVASIVE SQUAMOUS CELL CANCER OF THE SKIN IN ONE PATIENT EACH.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT 502 ADULT CONSECUTIVE PATIENTS RECEIVING HIGH DOSE BMP AT ONE INSTITUTION WERE ENROLLED IN THE STUDY. SURGERIES PERFORMED IN THE THORACIC AND LUMBAR SPINE WERE INCLUDED. MAJOR AND MINOR COMPLICATIONS WERE NOTED DURING INTRAOPERATIVE AND PERIOPERATIVE TIME POINTS. COMPLICATIONS POTENTIALLY ASSOCIATED WITH BMP SUCH AS RADICULOPATHY, STERILE SEROMAS AND CANCER WERE EVALUATED AND THEIR CORRELATION WITH BMP DOSE WAS EXAMINED. AN AVERAGE OF 115 MG OF BMP WAS USED; 265 PRIMARY AND 237 REVISION CASES, INCLUDING 110 ALIFS AND 151 TLIFS, WITH ON OVERAGE OF 11.5 INSTRUMENTED VERTEBRAE. AVERAGE FOLLOW UP WAS 42 MONTH (14-92). NO CORRELATION BETWEEN INCREASING BMP DOSAGE AND CANCER, RADICULOPATHY OR SEROMA WAS FOUND; 17 PATIENTS WERE DIAGNOSED WITH CANCER POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention