BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSLACE SPINAL TETHERING SYSTEM

    MDR report key: 8531075 · Received April 19, 2019

    Report

    Report Number
    1030489-2019-00442
    Event Type
    Injury
    Date Received
    April 19, 2019
    Report Date
    April 19, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    OWI
    UDI-DI
    00763000108380
    PMA / PMN Number
    K163181
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: OWI: BONE FIXATION CERCLAGE, SUBLAMINAR. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FUSION AND FIXATION AT T6-L3 DUE TO KYPHOSIS. AFTER APPROXIMATELY ONE WEEK POST-OP, PATIENT HAD FEVER. WHEN EVALUATION WAS PERFORMED, INFECTION WAS FOUND. HENCE, A REVISION SURGERY WAS PERFORMED FOR THE REMOVAL OF ALL IMPLANTS ON (B)(6) 2019. DURING THE REVISION SURGERY, IT WAS FOUND THAT THE CONNECTORS WERE VERY TIGHT AND IT WAS DIFFICULT TO REMOVE THE CONNECTORS. THE REMOVAL WAS CARRIED OUT BY GRASPING THE ROD WITH A ROD GRIPPER. NO TENSIONER WAS USED. THE SEVERITY OF THE INFECTION WAS DETERMINED TO BE NOT SERIOUS. ALLEGEDLY, THE PATIENT HAS STILL NOT RECOVERED. THE RELATEDNESS OF THE INFECTION WITH THE IMPLANTS OR SURGICAL PROCEDURE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324534 TRANSLACE SPINAL TETHERING SYSTEM OWI MEDTRONIC SOFAMOR DANEK USA, INC NA CT17F019 00763000108380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention