BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCLAVE ANTERIOR SPINAL SYSTEM

    MDR report key: 2450894 · Received February 14, 2012

    Report

    Report Number
    0002242816-2012-00013
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 16, 2012
    Report Date
    January 16, 2012
    Manufacturer
    EBI, LLC
    Product Code
    MAX
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS 2 OF 2 MDRS INVOLVED IN THE SAME EVENT. PLEASE SEE REPORT NUMBER: 2242816-2012-00012. IT SHOULD BE NOTED THAT THE FOLLOWING IS WRITTEN IN THE PRODUCT IFU: "PRIOR TO USE, INSTRUMENTS SHOULD BE VISUALLY INSPECTED AND FUNCTION SHOULD BE TESTED TO ASSURE INSTRUMENTS ARE FUNCTIONING PROPERLY. IF INSTRUMENTS ARE DISCOLORED, HAVE LOOSE SCREWS/PINS, ARE OUT OF ALIGNMENT, ARE CRACKED OR HAVE OTHER IRREGULARITIES, DO NOT USE."

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED INSTRUMENT CONFIRMED THAT THE TIP WAS BROKEN. A REVIEW OF THE MANUFACTURING RECORDS INDICATES THAT THERE WERE NO DIMENSIONAL, FUNCTIONAL OR MATERIAL ANOMALIES REPORTED AT INSPECTION AT THE TIME OF BUILD IN 2010. WITH THE AVAILABLE INFORMATION, WE HAVE CONCLUDED THE INSTRUMENT TIP BROKE DUE TO LARGER FORCES BEING USED ON IT THAN WHAT IT WAS DESIGNED FOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT WAS FRACTURED CAUSING A DELAY OF THIRTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCLAVE ANTERIOR SPINAL SYSTEM ENCLAVE TRIAL/RASP HANDLE MAX EBI, LLC N/A 34228

    Patients

    Seq Age Sex Outcome Treatment
    1