BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANET SPINE SYSTEM

    MDR report key: 6198025 · Received December 22, 2016

    Report

    Report Number
    3007675554-2016-00002
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 16, 2016
    Report Date
    December 20, 2016
    Manufacturer
    IMPLANET
    Product Code
    NKB
    PMA / PMN Number
    K143731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH ANALYSIS WAS PERFORMED: THE IMPLANTS CONCERNED ARE CONFORM TO IMPLANET SPECIFICATIONS. NO METALLOGRAPHIC EXPERTISE WILL BE CONDUCTED. THIS FRACTURE IS PROBABLY A FATIGUE FAILURE DUE TO EXCESSIVE SOLICITATION WHILE FUSION AT 1 YEAR IS NOT EFFECTIVE.

    Description of Event or Problem · 1

    INITIAL SURGERY ON (B)(6) 2015 WITH THE PHYSICIAN DR. (B)(6), 3 HOURS OF SURGERY FOR T3-L3 SCOLIOSIS. AN ARTHRODESIS WAS PERFORMED. NEW INTERVENTION REQUIRED PERFORMED ON (B)(6) 2016. THIS INTERVENTION WAS PERFORMED DUR TO LUMBAR PAIN: 2 POLYAXIAL SCREWS WERE BROKEN AND 2 DOMINOS, 3 SCREWS (WITH A LARGER DIAMETER) AND 4 JAZZ WERE PLACED INSTEAD . THE SURGEON TOOK OUT THE 2 BROKEN SCREWS AND 1 MORE IN L2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849644 IMPLANET SPINE SYSTEM POLYAXIAL PEDICLE SCREW NKB IMPLANET ISS POLYAXIAL SCREW DIAMETER 5 LENGTH 40 ENTS-ENTZ

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention 150000 (ELQU-DLVE)