BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    MDR report key: 3790126 · Received May 5, 2014

    Report

    Report Number
    2520274-2014-11109
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 16, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PT WEIGHT: WEIGHT NOT REPORTED. THIS REPORT IS FOR AN UNKNOWN SYNFIX-LR DEVICE, UNKNOWN PART NUMBER AND UNKNOWN LOT NUMBER. IMPLANT DATE: UNKNOWN. (B)(4). FRACTURE OF THE L-4 VERTEBRAL BODY AFTER USE OF A STAND-ALONE INTERBODY FUSION DEVICE IN DEGENERATIVE SPONDYLOLISTHESIS FOR ANTERIOR L3¿4 FIXATION. JOURNAL OF NEUROSURG: SPINE PP 1-4. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; THEREFORE, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE "FRACTURE OF THE L-4 VERTEBRAL BODY AFTER USE OF A STAND-ALONE INTERBODY FUSION DEVICE IN DEGENERATIVE SPONDYLOLISTHESIS FOR ANTERIOR L3¿4 FIXATION." A (B)(6)-YEAR-OLD MAN, PRESENTED WITH A COMPLAINT OF INTRACTABLE BACK, RIGHT-BUTTOCK, AND LEFT-LEG PAIN OVER A PERIOD OF SEVERAL WEEKS. THE PAIN WORSENED WITH AMBULATION. INITIAL RADIOGRAPHS SHOWED GRADE I DEGENERATIVE SPONDYLOLISTHESIS WITH INSTABILITY IN THE SAGITTAL PLANE (UPON 15° ROTATION) AND STENOSIS OF CENTRAL AND BOTH LATERAL RECESSES AT THE L3¿4 LEVEL. BONE DENSITY TESTING WAS NORMAL (T-SCORE = 1.0). INTENSIVE CONSERVATIVE MANAGEMENT OF PHYSICAL THERAPY AND EPIDURAL STEROID INJECTION BROUGHT NO SYMPTOMATIC RELIEF; THEREFORE, ALIF AT L3¿4 WAS CHOSEN, UTILIZING A STAND-ALONE CAGE/PLATE SYSTEM. FOLLOWING SURGERY, THE DEGENERATIVE SPONDYLOLISTHESIS ABATED AND SYMPTOMS RESOLVED. TWO MONTHS LATER, THE PATIENT RETURNED WITH BILATERAL LEG WEAKNESS AND BACK PAIN. BY MANUAL MUSCLE TESTING, SIGNIFICANT ANKLE DORSIFLEXION (GRADE 3) WAS NOTED BILATERALLY. PLAIN RADIOGRAPHS AND A COMPUTED TOMOGRAPHY SCAN SHOWED FAILURE OF THE DEVICE DUE TO ANTERIOR L-4 VERTEBRAL BODY FRACTURE, AND THE SPONDYLOLISTHESIS HAD RECURRED. BILATERAL FACETECTOMIES WERE THEN PERFORMED, WITH REDUCTION AND FIXATION AT L3¿4 BY PEDICLE SCREWS. AGAIN, DEGENERATIVE SPONDYLOLISTHESIS IMPROVED POSTSURGICALLY AND SYMPTOMS EASED, WITH EVENTUAL HEALING OF THE VERTEBRAL BODY FRACTURE. THE AUTHORS CONCLUDED THAT THIS CASE WAS A RARE INSTANCE OF L-4 VERTEBRAL BODY FRACTURE FOLLOWING THE USE OF A STAND-ALONE DEVICE FOR ALIF AT L3¿4, AND WAS LIKELY A CONSEQUENCE OF ANGULAR INSTABILITY IN DEGENERATIVE SPONDYLOLISTHESIS. IT WAS THEIR OPINION THAT UNDER SUCH CONDITIONS, ADDITIONAL PEDICLE SCREW FIXATION BE UTILIZED. THIS REPORT IS FOR AN UNKNOWN SYNFIX-LR CONSTRUCT; QUANTITY 1. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267064 INTERVERTEBAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention