BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1894910 · Received November 4, 2010

    Report

    Report Number
    1030489-2010-01436
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    February 8, 2010
    Report Date
    October 22, 2010
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE CITATION: CRAWFORD ET AL. EXTENSION OF PRIOR IDIOPATHIC SCOLIOSIS FUSIONS TO THE SACRUM; A MATCHED COHORT ANALYSIS OF SIXTY PTS WITH MINIMUM TWO-YR F/U. SPINE. 2010; VOLUME 35: NUMBER 20, PP 1843-1848. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LISTS FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. WITHOUT RETURN OF THE DEVICE OR ASSOCIATED RECORDS, IT IS NOT POSSIBLE TO ASCERTAIN A CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    A RETROSPECTIVE, SINGLE-INSTITUTION STUDY INCLUDED 36 CONSECUTIVE ADOLESCENT OR YOUNG ADULT PTS WHO, FROM 2002 TO 2006, UNDERWENT EXTENSION OF A PREVIOUS LONG SCOLIOSIS FUSION IN THE SACRUM/ILIUM USING RHBMP-2 WITHOUT AUTOGENOUS ILIAC CREST. ALL PTS UNDERWENT POSTERIOR EXTENSION OF AN EXISTING FUSION TO THE SACRUM WITH SEGMENTAL PEDICLE SCREW INSTRUMENTATION, INCLUDING S1 PEDICLE SCREW FIXATION AND ILIAC SCREW FIXATION. TWENTY-SIX PTS HAD ANTERIOR INTERBODY DEVICE SUPPORT AT THE LOWEST LEVEL VIA AN ANTERIOR APPROACH. ALL PTS HAD TWO-YR MINIMUM F/U. MEDICAL AND SURGICAL COMPLICATIONS WERE COLLECTED FROM THE HOSP AND POSTOPERATIVE VISIT OFFICE CHARTS, THE PROSPECTIVE DATABASE, AND SURGEON INTERVIEW. IN ONE PT, A DEEP WOUND INFECTION OCCURRED. NO SPECIFICS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT INFUSE BONE GRAFT NEK MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention