BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFELINK

    MDR report key: 752383 · Received August 24, 2005

    Report

    Report Number
    MW1036429
    Event Type
    Injury
    Date Received
    August 24, 2005
    Report Date
    August 24, 2005
    Manufacturer
    LIFELINK
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    A POSTERIOR SPINAL FUSION WAS CONDUCTED ON MY DAUGHTER FOR IDIOPATHIC SCOLIOSIS. THE POSTERIOR SPINAL FUSION WAS FROM THE T# TO L2 WITH SPINAL INSTRUMENTATION AND BONE AUTO AND ALLOGRAFT. THE HARDWARE/IMPLANTS WERE MANUFACTURED BY LIFELINK. REO SCREWS,PEDICLE HOOKS, CONNECTORS CLIPS AND RODS WERE USED. PATIENT EXPERIENCED SEVERE PAIN ON LEFT SHOULDER OCCURRING 3 MONTHS AFTER INITIAL SURGERY. FURTHER TESTING, PAIN MANAGEMENT WAS CONDUCTED TO EXPLORE REASON FOR SEVERE PAIN. DECISION WAS MADE AFTER FINDING NEW SURGEON TO REMOVE HARDWARE. DURING THE SURGERY IT WAS NOTED THAT "THE SUPERIOR CROSS-LINK DEVICE WAS FRACTURED AND THERE WAS SOME REACTION OF THE TISSUES AROUND THE CROSS-LINK DEVICE. THE DEVICE HAD FAILED WITHIN 3 MONTHS OF IMPLANT. THE IMPLANT RECORD DOES NOT IDENTIFY THE "CROSS-LINK" DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELINK * MCV LIFELINK REO *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization