BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3221653 · Received July 11, 2013

    Report

    Report Number
    1030489-2013-03007
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: BEIDAS ET AL. SAFETY AND EFFICACY OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN 2 ON CRANIAL DEFECT CLOSURE IN THE PEDIATRIC POPULATION. THE JOURNAL OF CRANIOFACIAL SURGERY: 2013;24: 917-922. A2: AVERAGE AGE: 4.6 (RANGE 2-11) YRS. D6: JANUARY 2005 ¿ JANUARY 2010. (B)(6). (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

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT PATIENTS WERE IDENTIFIED FROM A PROSPECTIVE DATABASE FOR A RETROSPECTIVE REVIEW AT TWO INSTITUTIONS. INFORMATION WAS EXTRACTED FROM CHARTS, OPERATIVE RECORDS, AND COMPUTED TOMOGRAPHIC (CT) STUDIES. INCLUSION CRITERIA WERE PATIENTS YOUNGER THAN 16 YEARS AT THE TIME OF SURGERY WHO UNDERWENT CRANIAL DEFECT CLOSURE, WITH PREOPERATIVE AND POSTOPERATIVE CT SCANS AVAILABLE ON RECORD. PATIENTS WITH DEFECTS THAT WERE THE RESULT OF TRAUMA WERE EXCLUDED. PATIENTS WITHOUT COMPLETE IMAGING RECORDS WERE ALSO EXCLUDED. TO QUALIFY FOR RHBMP-2, PATIENTS MUST BE OLDER THAN 3.5 YEARS AND HAVE INSUFFICIENT DONOR SITES FOR AN OPTIMAL AUTOGENOUS BONE CRANIOPLASTY. THE PATIENTS UNDERWENT AUTOGENOUS CRANIOPLASTY WITH CALVARIAL SHAVINGS USING INSTRUMENTATION. RECOMBINANT HUMAN BMP-2 WAS OFFERED IN ONLY 1 INSTITUTION. A TOTAL OF 36 PATIENTS WERE ELIGIBLE FOR THIS STUDY: 15 IN THE CONTROL GROUP AND 21 IN THE TREATMENT GROUP. THERE WERE A TOTAL OF 22 SURGERIES OWING TO 1 PATIENT IN THE TREATMENT GROUP WHO HAD 2 INDICATED PROCEDURES DURING THE STUDY PERIOD. THE MOST RECENT PREOPERATIVE CTS AND ALL POSTOPERATIVE CTS WERE ANALYZED FOR EACH PATIENT. TOTAL PREOPERATIVE DEFECT SIZE, OR THE SUMMATION OF ALL DEFECTS PER PATIENT, WAS, ON AVERAGE, 10.09 CM2 FOR THE CONTROL GROUP AND 8.64 CM2 FOR THE TREATMENT GROUP. TOTAL POSTOPERATIVE DEFECT SIZE WAS 2.13 AND 1.36 CM2 FOR THE CONTROL AND TREATMENT GROUPS, RESPECTIVELY. FOLLOW-UP PERIOD FOR THE CONTROL GROUP WAS 16 MONTHS AND THAT FOR THE TREATMENT GROUP WAS 5 MONTHS. ONE PATIENT HAD LATE-ONSET ELEVATED INTRACRANIAL PRESSURE THAT BEGAN 6 MONTHS AFTER SURGERY AND PHOTOPHOBIA THAT PRESENTED 12 MONTHS AFTER SURGERY; THIS PATIENT WAS LATER DIAGNOSED WITH CROUZON SYNDROME AND CORRECTED WITH A SECONDARY CRANIAL VAULT EXPANSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320666 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 00005 YR Other