BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2880117 · Received December 19, 2012

    Report

    Report Number
    1030489-2012-02893
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 24, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: KLIMO ET AL. OCCIPITOCERVICAL FUSION USING A CONTOURED ROD AND WIRE CONSTRUCT IN CHILDREN: A REAPPRAISAL OF A VINTAGE TECHNIQUE. J NEUROSURG: PEDIATRICS. NOVEMBER 16, 2012; (DOI: 10.3171/2012.9.PEDS12214). (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 THE AUTHORS REVIEWED THE MEDICAL RECORDS OF PATIENTS 18 YEARS OF AGE OR YOUNGER WHO UNDERWENT DORSAL OCCIPITOCERVICAL FUSION PROCEDURES USING A CONTOURED ROD AND WIRE CONSTRUCT. TWENTY PATIENTS WERE IDENTIFIED. SURGICAL STABILIZATION EXTENDED FROM THE OCCIPUT TO C-1 IN 3 PATIENTS, C-2 IN 6, C-3 IN 8, AND TO C-4 IN 3. BONE MORPHOGENETIC PROTEIN WAS USED IN 2 PATIENTS. ONE PATIENT HAD CHRONIC NECK PAIN. IT WAS NOT REPORTED IF THIS PATIENT HAD RECEIVED BMP.

    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 00006 YR Required Intervention