BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERFUSE INTERVERTEBRAL BODY FUSION SYSTEM

    MDR report key: 1828688 · Received September 2, 2010

    Report

    Report Number
    3007617183-2010-00001
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 31, 2010
    Manufacturer
    VERTEBRAL TECHNOLOGIES INC.
    Product Code
    MAX
    PMA / PMN Number
    K091988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE TWO DEVICES IMPLANTED, ONE AT EACH LEVEL, OF WHICH BOTH HAVE THE SAME MODEL AND CATALOG NUMBERS. THE LOT NUMBER, EXPIRATION DATE AND DEVICE MANUFACTURE DATE FOR THE SECOND DEVICE ARE 091217-01, 12/31/2011 AND 12/2009 RESPECTIVELY. THE UNIQUE DISC SPACE LOCATION FOR EACH DEVICE IS NOT KNOWN.

    Description of Event or Problem · 1

    INTERFUSE DEVICES WERE INSERTED AT LEVELS L4-L5 AND L5-S1 DISC SPACES ON (B)(6)2010. PATIENT DID WELL IN EARLY POST OP COURSE. PATIENT RETURNED WITH RECURRENCE OF BACK AND LEG PAIN IN (B)(6) 2010. IMAGES TAKEN INDICATED MIGRATION OF TWO OF THE INTERFUSE SEGMENTS AT THE L5-S1 LOCATION CAUSING MODERATE TO SEVERE STENOSIS AND DAMAGE TO THE LEFT S1 SCREW. THE SCREW WAS BROKEN IN HALF AT THE SHAFT. PATIENT SAID HE DID NOT FALL BUT HAD BEEN AT WORK LIFTING HEAVY LOADS. SURGICAL INTERVENTION OCCURRED ON (B)(6)2010. THE INTERFUSE DEVICE WAS REMOVED AND REPLACED WITH A TLIF CAGE AT THE L5-S1 LOCATION. THE BROKEN SCREW WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFUSE INTERVERTEBRAL BODY FUSION SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX VERTEBRAL TECHNOLOGIES INC. 9076-10-20-5 091002-10

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R