BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06522

    MDR report key: 3366913 · Received September 25, 2013

    Report

    Report Number
    2520274-2013-06522
    Event Type
    Injury
    Date Received
    September 25, 2013
    Report Date
    September 13, 2013
    Manufacturer
    SYNTHES, USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: SPINE (2012) 37 (20): 1785-1789. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS MEDWATCH IS BEING RESCINDED AND HAS BEEN DETERMINED TO BE NOT REPORTABLE. DUE TO FURTHER INFORMATION LEARNED FROM THE ARTICLE AND CONFIRMED BY THIS MANUFACTURERS PRODUCT DEVELOPMENT EVENT EVALUATION RESULTS WHICH INDICATE THAT THE DEVICES REPORTED ARE NOT REASONABLY ASSOCIATED WITH THIS REPORTED EVENT. THE MANUFACTURERS DEVICES ARE USED IN THE PROCEDURE SUBSEQUENT TO THE REPORTED EVENT. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. IN THE DESIGN EVALUATION, IT WAS REPORTED THAT RETROGRADE EJACULATION IS CAUSED BY DAMAGE TO THE SUPERIOR HYPOGASTRIC PLEXUS WITHIN THE BIFURCATION OF THE AORTA IN THE RETROPERITONEAL SPACE. THIS PLEXUS INNERVATES THE INTERNAL VESICLE SPHINCTER WHICH IS INVOLVED IN THE NORMAL EJACULATORY REFLEX. GAINING ACCESS TO THE L5-S1 DISC SPACE AT L5-S1, AS PERFORMED IN THIS STUDY, INVOLVES DISSECTING AND RETRACTING THE TISSUE CONTAINING THESE NERVE FIBERS PRIOR TO THE INSTRUMENTATION PORTION OF THE PROCEDURE (BEFORE DISCECTOMY AND INTERVERTEBRAL DEVICE TRIALING AND PLACEMENT). AS DESCRIBED IN THE ANTERIOR ACCESS TO THE LUMBAR SPINE TECHNIQUE GUIDE: RETROGRADE EJACULATION IS FORTUNATELY AN UNCOMMON COMPLICATION THAT IS ALMOST EXCLUSIVELY RELATED TO L5-S1 APPROACHES. THE SUPERIOR HYPOGASTRIC PLEXUS TRAVELS WITH THE PERITONEUM AND THE RETROPERITONEAL FAT COURSING OVER THE BIFURCATION OF THE AORTA DOWN THE MIDLINE OVER THE PROMONTORY.... IN ORDER TO AVOID DAMAGE TO THIS STRUCTURE, BLUNT DISSECTION SHOULD BE STARTED RIGHT AT THE ANTERIOR WALL OF THE LEFT ILIAC ARTERY JUST LATERAL TO THE URETER. THE URETER AND PERITONEUM ARE THEN LIFTED AWAY, AND IN DOING SO, THE NERVE FIBERS GO WITH THE PERITONEUM. THIS BLUNT FINGER OR KITTNER DISSECTION IS THEN CARRIED SUPERIORLY AND FAR TO THE RIGHT WHILE HUGGING THE PROMONTORY.... ONCE THE MIDDLE SACRAL VESSELS ARE CLEARLY VISIBLE, THE NEVER FIBERS SHOULD BE OUT OF HARMS WAY AND CLIPS AND CAUTERY CAN BE USED TO CONTROL THE VESSELS. IN THINNER PATIENTS, THESE FIBERS CAN BE CLEARLY SEEN AND AVOIDED. THERE IS NO ADVANTAGE TO APPROACHING L5-S1 WITH A RETROPERITONEAL APPROACH FROM THE RIGHT JUST TO AVOID DAMAGE TO THIS NERVE PLEXUS. IN THIS ARTICLE, THE AUTHORS FOUND THERE WERE NO SPECIFIC DIFFERENCE IN THE RATE OF RETROGRADE EJACULATION BETWEEN THE ANTERIOR LUMBAR INTERBODY FUSION WITH BONE MORPHOGENETIC PROTEIN, AND ARTIFICIAL DISC REPLACEMENT. THEY REACHED THE CONCLUSION THAT THE RETROPERITONEAL APPROACH, NOT THE DEVICES OR BMP USED, SEEMED TO BE RESPONSIBLE FOR THIS COMPLICATION. NO INSTRUMENTS ARE PROVIDED IN EITHER THE ANTERIOR TENSION BAND, SYNFIX-LR, OR PRODISC-L SYSTEMS USED IN THIS STUDY THAT ARE INTENDED TO BE USED DURING THE ACCESS PORTION OF THE PROCEDURE WHERE THEY WOULD CONTACT THESE NERVOUS STRUCTURES. NO SPECIFIC INSTRUMENTS OR IMPLANTS FROM THESE SYSTEMS WERE NOTED AS POTENTIALLY CONTRIBUTING TO THE POTENTIAL DAMAGE TO THE SUPERIOR HYPOGASTRIC PLEXUS. RETROGRADE EJACULATION CONTINUES TO BE A GENERIC RISK OF ANTERIOR ACCESS TO THE LUMBAR SPINE AND NOT ATTRIBUTABLE TO A SPECIFIC DEVISE OR DESIGN FEATURE. IN CONCLUSION, RETROGRADE EJACULATION IS A GENERIC ANTERIOR LUMBAR SURGICAL RISK CAUSED FROM DAMAGE TO THE SUPERIOR HYPOGASTRIC PLEXUS DURING ANTERIOR ACCESS TO THE L5-S1 DISC SPACE. INSTRUMENTS AND IMPLANTS IN THE ANTERIOR TENSION BAND, SYNFIX-LR, AND PRODISC-L SYSTEMS IDENTIFIED IN THIS STUDY ARE PROVIDED FOR USE ONCE SUFFICIENT EXPOSURE TO THE ANTERIOR DISC SPACE HAS BEEN ACHIEVED, NOT FOR USE DURING THIS ACCESS PHASE OF THE PROCEDURE. NO SPECIFIC INSTRUMENTS OR IMPLANTS IN THESE SYSTEMS WERE IDENTIFIED AS HARMING THE SUPERIOR HYPOGASTRIC PLEXUS DURING THE INSTRUMENTATION PORTION OF THE PROCEDURE.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: RETROGRADE EJACULATION AFTER ANTERIOR LUMBAR SPINE SURGERY; LINDLEY, E.M., MCBETH Z.L., HENRY S.E., COOLEY R., BURGER E.L., CAIN C.M.J., PATEL V.V.; SPINE (2012) 37 (20): 1785-1789; REPORTED: A RETROSPECTIVE COHORT STUDY TO DETERMINE THE INCIDENCE OF RETROGRADE EJACULATION (RE) AFTER TREATMENT WITH EITHER ANTERIOR LUMBAR INTERBODY FUSION (ALIF) USING RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (BMP) OR ANTERIOR LUMBAR SPINE SURGERY WITH ARTIFICIAL DISC REPLACEMENT (ADR). FIFTY FOUR PATIENTS UNDERWENT ALIF WITH BMP AND 41 PATIENTS UNDERWENT ADR; AVERAGE AGES WERE 49 AND 35 YEARS RESPECTIVELY. PATIENTS IN THE ALIF WITH BMP GROUP RECEIVED EITHER AN ANTERIOR PLATE WITH FOUR SCREWS (ANTERIOR TENSION BAND PLATE; SYNTHES) AND FEMORAL RING ALLOGRAFT OR AN INTEGRATED CAGE/PLATE DEVICE WITH FOUR SCREWS (SYNFIX-LR; SYNTHES). THE INTERBODY DEVICES CONTAINED ONE TO TWO SPONGES OF BMP. PATIENTS IN THE ADR GROUP RECEIVED EITHER PRODISC-L (SYNTHES) OR AN ARTIFICIAL DISC IMPLANT OF A COMPETITOR. FOUR PATIENTS IN EACH TREATMENT GROUP EXPERIENCED POSTOPERATIVE RE. ONE PATIENT IN EACH TREATMENT GROUP REPORTED RESOLUTION OF THEIR SYMPTOMS. TWO PATIENTS IN THE ALIF WITH BMP GROUP ALSO EXPERIENCED SEXUAL DYSFUNCTION DESCRIBED AS A DECREASE IN SEXUAL DESIRE, PAINFUL ERECTION AND DIFFICULTY OBTAINING AN ERECTION, IN ADDITION TO RE. ONE PATIENT EXPERIENCED TRANSIENT POSTOPERATIVE RE. THIS EVENT WAS REPORTED DURING A FOLLOW-UP TELEPHONE CALL AND HAD NOT BEEN DOCUMENTED IN MEDICAL RECORDS. THE TREATMENT GROUP WAS NOT IDENTIFIED. THE AUTHORS CONCLUDED THAT RE OCCURRED AT A SIMILAR RATE OF INCIDENCE IN PATIENTS TREATED WITH ALIF WITH BMP AND ADR. THIS REPORT IS FOR AN UNKNOWN ANTERIOR TENSION BAND PLATE. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483465 HRS SYNTHES, USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention