BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2851259 · Received November 29, 2012

    Report

    Report Number
    1030489-2012-02481
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: WANG ET AL. THIRTY-DAY READMISSIONS AFTER ELECTIVE SPINE SURGERY FOR DEGENERATIVE CONDITIONS AMONG US MEDICARE BENEFICIARIES. THE SPINE JOURNAL (2012). MEAN AGE (CERVICAL) 72.5 YRS. MEAN AGE (LUMBAR) 74.1 YRS. DATES OF IMPLANT: 2003-2007. (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 A RETROSPECTIVE COHORT STUDY OF 343,068 MEDICARE BENEFICIARIES WHO UNDERWENT ELECTIVE CERVICAL AND LUMBAR SPINE SURGERY FOR DEGENERATIVE CONDITIONS WAS CONDUCTED. READMISSIONS WITHIN 30 DAYS OF DISCHARGE, EXCLUDING READMISSIONS FOR REHABILITATION, WERE RECORDED: 329 PATIENTS UNDERWENT CERVICAL FUSION USING BMP; 2211 PATIENTS UNDERWENT LUMBAR FUSION USING BMP. BMP-AUGMENTED FUSIONS WERE MORE COMMON IN THE LUMBAR COHORT (23% OF FUSIONS) COMPARED WITH THE CERVICAL COHORT (6.2% OF FUSIONS). SURGICAL APPROACH ALSO DIFFERED BETWEEN THE CERVICAL AND LUMBAR SPINE PATIENTS. THE CERVICAL COHORT MOST COMMONLY UNDERWENT SURGERY FROM AN ANTERIOR APPROACH (67.0%) COMPARED WITH THE LUMBAR COHORT, WHICH MORE COMMONLY UNDERWENT SURGERY FROM THE POSTERIOR APPROACH (98.3%). THE USE OF BMP DID NOT ADD A SIGNIFICANTLY INCREASED RISK BEYOND THE NUMBER OF LEVELS FUSED; 9 PATIENTS DEVELOPED RESPIRATORY FAILURE REQUIRING READMISSION WITHIN 30 DAYS FOLLOWING A CERVICAL FUSION PROCEDURE WITH 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 Hospitalization| R