BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAZZ

    MDR report key: 6307077 · Received February 7, 2017

    Report

    Report Number
    3007675554-2017-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Report Date
    February 6, 2017
    Manufacturer
    IMPLANET
    Product Code
    OWI
    PMA / PMN Number
    K160226
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE BATCH RECORD DID NOT SHOW ANY NON CONFORMITY. THE PRODUCTS ARE CONFORM TO IMPLANET SPECIFICATIONS.

    Description of Event or Problem · 1

    INITIAL SURGERY : (B)(6) 2015. PATIENT RETURNED TO SURGEON TWO YEARS AFTER THE INITIAL SURGERY, COMPLAINING OF DISCOMFORT. IT WAS DETERMINED THAT SCREWS AT S1 HAD PULLED OUT AND THAT THE TWO MOST PROXIMAL JAZZ BANDS IMPLANTED HAD BROKEN. THE SURGEON EXTENDED THE CONSTRUCT UP TWO LEVELS TO T6 AND DOWN A LEVEL TO THE PELVIS. IT SHOULD BE NOTED THAT THE TWO JAZZ THAT BROKE WERE IMPLANTED AT THE PROXIMAL END OF THE CONSTRUCT WITHOUT SUPPORT OF SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91905 JAZZ MULTI-PURPOSE SPINE CONNECTOR OWI IMPLANET DROZ0016

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention