BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANET SPINE SYSTEM

    MDR report key: 4867625 · Received June 24, 2015

    Report

    Report Number
    3007675554-2015-00001
    Event Type
    Injury
    Date Received
    June 24, 2015
    Date of Event
    September 24, 2014
    Report Date
    June 5, 2015
    Manufacturer
    IMPLANET
    Product Code
    NKB
    PMA / PMN Number
    K120564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING SUDDEN PAIN, RADIOGRAPHIES SHOWED THAT TWO S1 SCREWS BROKE. A SECOND INTERVENTION HAS BEEN PERFORMED ON (B)(6) 2015: THE FOUR SCREWS AND THE TWO RODS HAVE BEEN TAKEN OUT AND REPLACED.

    Description of Event or Problem · 1

    INITIAL SURGERY ON (B)(6) 2014 FOR DISCOPATHY INSTABILITY ON L5S1. IMMEDIATE POST-OPERATIVE RADIOGRAPHIES WERE NORMAL AS WELL AS ONE MONTH LATER. TWO S1 POLYAXIAL SCREWS BROKE ON A L5S1 ARTHRODESIS TWO MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407794 IMPLANET SPINE SYSTEM NKB IMPLANET DIAMETER7 LENGTH35 DKNY-DKOC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention 2 SCREWS 150013 POLYAXIAL PEDICLE SCREWS DIAMETER