BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAZZ LOCK

    MDR report key: 7057739 · Received November 24, 2017

    Report

    Report Number
    3007675554-2017-00003
    Event Type
    Injury
    Date Received
    November 24, 2017
    Date of Event
    November 3, 2017
    Report Date
    November 21, 2017
    Manufacturer
    IMPLANET
    Product Code
    OWI
    PMA / PMN Number
    K153348
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FIRST SURGERY IN (B)(6) 2016 FOR C1-C2 LUXATION: 2 JAZZ LOCK IMPLANTED. REVISION SURGERY DUE TO RECURRENCE LUXATION IN (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836702 JAZZ LOCK JAZZ LOCK OWI IMPLANET 150700 GGYK-GGXL

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention