BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1705945 · Received May 28, 2010

    Report

    Report Number
    1030489-2010-00728
    Event Type
    Injury
    Date Received
    May 28, 2010
    Date of Event
    December 7, 2008
    Report Date
    April 28, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) - PSEUDOARTHROSIS - (B) (4). LITERATURE ARTICLE CITATION: ACOSTA F. PATIENT SATISFACTION AND RADIOGRAPHIC OUTCOMES AFTER LUMBAR SPINAL FUSION WITHOUT ILIAC CREST BONE GRAFT OR TRANSVERSE PROCESS FUSION" IN THE JOURNAL OF CLINICAL NEUROSCIENCE (2009; 16: 1184-1187); (10.1016/J.JOCN.2008.12.006). A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. 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 THAT THE PATIENT UNDERWENT A LAMINECTOMY FOLLOWED BY POSTERIOR SPINAL FUSION USING PEDICLE SCREW-ROD FIXATION. THE PATIENT ALSO UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) USING RHBMP-2/ACS. AT AN UNKNOWN TIME POST-OP, THE PATIENT WAS DIAGNOSED WITH PSEUDOARTHROSIS. THE PATIENT UNDERWENT REVISION FUSION WITH ANTERIOR LUMBAR INTERBODY FUSION (ALIF) AND POSTERIOR FIXATION.

    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 Required Intervention IMPLANT:| IMPLANT:| PEDICLE SCREW| EXPLANT:| ROD| EXPLANT: