BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2912020 · Received January 11, 2013

    Report

    Report Number
    1030489-2013-00123
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: LUBELSKI ET AL. UROLOGICAL COMPLICATIONS FOLLOWING USE OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN - 2 IN ANTERIOR LUMBAR INTERBODY FUSION. J NEUROSURG: SPINE (DECEMBER 14, 2012). (B)(6). IMPLANT DATE: (B)(6) 2002 - (B)(6) 2010. (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 REVIEW WAS CONDUCTED OF THE MEDICAL RECORDS OF ALL PATIENTS WHO UNDERWENT ALIF WITH AND WITHOUT RHBMP-2. PATIENT DEMOGRAPHIC, OPERATIVE, AND COMPLICATION INFORMATION WAS ANALYZED. MALE PATIENTS WHO UNDERWENT ALIF BETWEEN L-4 AND S-1 WERE CONTACTED TO ASSESS POSTOPERATIVE UROLOGICAL COMPLICATIONS. OF THE 110 MALE PATIENTS WHO UNDERWENT ALIF AND WERE INCLUDED IN THIS STUDY, 59 WERE TREATED WITH RHBMP-2 AND 51 DID NOT RECEIVE RHBMP-2. THE MEAN FOLLOW-UP DURATION WAS 17.5 MONTHS FOR THE RHBMP-2 GROUP AND 30.8 MONTHS FOR THE CONTROL GROUP. THIRTEEN (13) PATIENTS IN THE RHBMP-2 COHORT DEVELOPED UROLOGICAL COMPLICATIONS. IN THIS STUDY, THE USE OF RHBMP-2 WITH ALIF SURGERY WAS NOT ASSOCIATED WITH AN INCREASED INCIDENCE OF UROLOGICAL COMPLICATIONS AND RETROGRADE EJACULATION WHEN COMPARED WITH CONTROL ALIF WITHOUT RHBMP-2. FOUR (4) PATIENTS HAD EJACULATION PAIN/DIFFICULTY POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18635 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 00051 YR Other