BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE OCT SYSTEM

    MDR report key: 8626306 · Received May 20, 2019

    Report

    Report Number
    2031966-2019-00196
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    February 1, 2019
    Report Date
    April 26, 2019
    Manufacturer
    NUVASIVE INC.
    Product Code
    MNI
    UDI-DI
    00887917176196
    PMA / PMN Number
    K071435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT LOT INFORMATION PROVIDED AND NO DEVICE RETURNED FOR EVALUATION. NO RADIOGRAPHS OR CT IMAGES RECEIVED THEREFORE ALLEGED MALFUNCTION COULD NOT BE CONFIRMED. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. NO PATIENT INJURY REPORTED. LABELING REVIEW: "CARE SHOULD BE USED IN THE HANDLING AND STORAGE OF THE IMPLANTS. THE IMPLANTS SHOULD NOT BE SCRATCHED OR DAMAGED. IMPLANTS AND INSTRUMENTS SHOULD BE PROTECTED DURING STORAGE AND FROM CORROSIVE ENVIRONMENTS. ALL NON-STERILE PARTS SHOULD BE CLEANED AND STERILIZED BEFORE USE. DEVICES SHOULD BE INSPECTED FOR DAMAGE PRIOR TO IMPLANTATION. CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT". "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S), LOSS OF FIXATION". "PREOPERATIVE INSTRUCTIONS TO THE PATIENT ARE ESSENTIAL. THE PATIENT SHOULD BE MADE AWARE OF THE LIMITATIONS OF THE IMPLANT AND POTENTIAL RISKS OF THE SURGERY. THE PATIENT SHOULD BE INSTRUCTED TO LIMIT POSTOPERATIVE ACTIVITY, AS THIS WILL REDUCE THE RISK OF BENT, BROKEN OR LOOSE IMPLANT COMPONENTS. THE PATIENT MUST BE MADE AWARE THAT IMPLANT COMPONENTS MAY BEND, BREAK OR LOOSEN EVEN THOUGH RESTRICTIONS IN ACTIVITY ARE FOLLOWED". "ALL IMPLANTS SHOULD BE USED ONLY WITH THE APPROPRIATELY DESIGNATED INSTRUMENT (REFERENCE SURGICAL TECHNIQUE)".

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE WITHOUT ANY REPORTED ISSUES. ON (B)(6) 2019 A REVISION PROCEDURE WAS PERFORMED TO REPLACE A BACKED OUT LOCK SCREW. NO ADDITIONAL INFORMATION PROVIDED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416107 NUVASIVE OCT SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM. MNI NUVASIVE INC. 7903006 00887917176196

    Patients

    Seq Age Sex Outcome Treatment
    1