BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFIRM INFLATABLE BONE TAMP PACK, ULTRA, 15U

    MDR report key: 3853383 · Received April 7, 2014

    Report

    Report Number
    3004142400-2014-00015
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION, HOWEVER A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS ACCORDING TO THE DESCRIPTIONS OF THE PRODUCT USED WITH THE CONCOMITANT DEVICE. ALL RECORDS REVEALED ALL PRODUCT LOTS WERE MANUFACTURED WITHIN SPECIFICATIONS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AN OPERATING PROCEDURES. SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATIONS, THE IMPACT OF CLAMPING THE LUMEN CANNOT BE ACCESSED, NOT COULD THE ROOT CAUSE OF THE FAILURE OF THE BALLOON TO DELATE BE DETERMINED. CLOSING THE LUMEN OF THE BONE TAMP IS NOT MENTIONED IN THE AFFIRM LITERATURE. THE EXACT CAUSE OF THE REPORTED ISSUE CANNOT BE ASCERTAINED.

    Description of Event or Problem · 1

    DR WAS PERFORMING A T-10 KYPHOPLASTY, WHEN IT CAME TIME TO DEFLATE THE BALLOON IT WOULD NOT DEFLATE. DR HAD CLAMPED TO LUMEN OF THE BALLOON NEAR THE PROXIMAL END OF THE WORKING CANNULA. HE REMOVE THIS CLAMP PRIOR TO ATTEMPTING TO DEFLATE THE BALLOON. HE ALSO ATTACHED A LOCKING SYRINGE DIRECTLY TO THE BLUE PORT OF THE BALLOON TO TRY AND SUCK OUT THE CONTRAST. HE FINALLY GRABBED THE TOP OF THE BALLOON. HE ALSO ATTACHED A LOCKING SYRINGE DIRECTLY TO THE BLUE PORT OF THE BALLOON TO TRY AND SUCK OUT THE CONTRAST. HE FINALLY GRABBED THE TOP OF THE BALLOON AND FORCEFULLY TRIED TO PULL IT BACK THROUGH THE CANNULA. THE BALLOON THEN DETACHED FROM THE LUMEN. THE LUMEN AND INNER WIRING CAME OUT AND THE RUPTURED BALLOON STAYED INSIDE THE PATIENT, INSIDE THE VERTEBRAL BODY. CEMENT WAS THEN INJECTED AS USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209683 AFFIRM INFLATABLE BONE TAMP PACK, ULTRA, 15U AFFIRM INFLATABLE BONE TAMP NDN GLOBUS MEDICAL, INC. 658.352S GBP283GF

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other