BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY SPINAL SYSTEM

    MDR report key: 845764 · Received March 6, 2007

    Report

    Report Number
    2242816-2007-00011
    Event Type
    Malfunction
    Date Received
    March 6, 2007
    Date of Event
    January 31, 2007
    Report Date
    March 5, 2007
    Manufacturer
    EBI
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT STATES THAT DURING SURGERY DOCTOR USED PEDICLE SCREWS TO SECURE DISC FUSION OF L4-L5-S1. L4-5 HAS HEALED BUT S1 HAS NOT BECAUSE SCREWS BROKE. PT OUTCOME: CONSTANT PAIN AND HAS NUMBNESS IN LEFT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY SPINAL SYSTEM NKB NKB EBI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR