BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2132855 · Received June 17, 2011

    Report

    Report Number
    1030489-2011-00762
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - (RETROGRADE EJACULATION).

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: CARRAGEE, EJ ET AL. RETROGRADE EJACULATION AFTER ANTERIOR LUMBAR INTERBODY FUSION USING RHBMP-2: A COHORT CONTROLLED STUDY. SPINE JOURNAL. 25 MAY 2011: THE AVERAGE AGE OF THE STUDY PATIENTS WAS (B)(6) YEARS; THE AGES RANGED FROM 22-65: THE AVERAGE WEIGHT OF THE STUDY PATIENTS WAS (B)(6) KG: FEMORAL RING ALLOGRAFT, MESH CAGE, ALLOGRAFT AND/OR POSTERIOR INSTRUMENTATION (DETAILS NOT PROVIDED): (B)(4) - RETROGRADE EJACULATION / C64343; C05681: C3046; C76126. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. MULTIPLE PRODUCTS 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. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. (B)(4).

    Description of Event or Problem · 1

    POST-OPERATIVE COMPLICATIONS WERE REPORTED IN A RETROSPECTIVE ANALYSIS OF 69 MALE PATIENTS WITH LUMBAR SPONDYLOSIS OR SPONDYLOLISTHESIS WHO UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) AT L4/L5 AND/OR L5/S1 WITH RHBMP-2. EITHER A TRANSRECTUS RETROPERITONEAL OR ANTERIOR LATERAL RETROPERITONEAL APPROACH WAS USED. NO ELECTROCAUTERY WAS USED AT THE LEVEL OF BIFURCATION OF THE DEEP VESSELS OR AROUND THE L5/S1 DISC. A FEMORAL RING ALLOGRAFT (FRA) OR TITANIUM MESH CAGE WAS PLACED INSIDE THE DISC SPACE. RHBMP-2 WAS PLACED INSIDE FRA CENTRAL CANAL. UNLESS A FOUR-HOLE PLATE WAS USED IN A STAND-ALONE CONFIGURATION, A BUTTRESS SCREW WAS PLACED, USUALLY, INTO THE CAUDAL VERTEBRAE JUST BELOW THE END PLATE. POSTERIOR INSTRUMENTATION, EITHER UNILATERAL OR BILATERAL, WAS PLACED AS DEEMED NECESSARY BY THE PATHOLOGIC INSTABILITY OF THE SEGMENT OR BONE QUALITY. FIVE PATIENTS DEVELOPED RETROGRADE EJACULATION (RE). THREE PATIENTS HAD UNDERGONE SINGLE LEVEL ALIF AND TWO PATIENTS UNDERWENT BILEVEL ALIF. THE RE OCCURRED AFTER ALIF WITH FRA SPACERS. OF THE FIVE PATIENTS HAVING AN RE EVENT, THREE HAD SOME APPARENT EARLY OSTEOLYSIS APPRECIABLE BY PLAIN RADIOGRAPH IN THE EARLY POSTOPERATIVE PERIOD. ONE PATIENT HAD AN EXTENSIVE OSTEOLYSIS WITH A FRACTURE OF THE ANTERIOR HALF OF THE SACRAL BODY. THIS HEALED IN TIME WITHOUT GROSS DISPLACEMENT (THERE HAD BEEN SUPPLEMENTAL FIXATION AT THE FIRST SURGERY). THE RE WAS APPRECIATED BEFORE THE FRACTURE WAS APPARENT ON RADIOGRAPHS. ONE YEAR AFTER SURGERY, TWO OF THE FIVE PATIENTS REPORTED RESOLUTION OF THE RE. TWO PATIENTS DID NOT RECOVER.

    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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR