BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSLACE SPINAL TETHERING SYSTEM

    MDR report key: 11775897 · Received May 5, 2021

    Report

    Report Number
    1030489-2021-00570
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 14, 2021
    Report Date
    May 5, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    OWI
    PMA / PMN Number
    K163181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR ADJACENT JOINT DISEASE. IT WAS REPORTED THAT WHEN ATTEMPTED TO APPLY TENSION TO THE TETHER, THE TETHER BROKE AT THE TENSIONER LEVER FIXING PART. IT DID NOT TRY TO RESET IT BUT PULLED THE TETHER ACCORDING TO THE MANUAL TO PERFORM THE FINAL TIGHTENING AND THE TETHER WAS CONTINUED TO BE IMPLANTED AS IT WAS. THERE WAS DELAY OF LESS THAN 60MIN IN OVERALL PROCEDURE TIME. THERE WERE NO FRAGMENTS OF INSTRUMENT LEFT IN THE PATIENT BODY. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673816 TRANSLACE SPINAL TETHERING SYSTEM OWI MEDTRONIC SOFAMOR DANEK USA, INC 8219500 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1