BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSB GLOBAL SPINAL BALANCE SYSTEM

    MDR report key: 6155797 · Received December 8, 2016

    Report

    Report Number
    2031966-2016-00088
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 10, 2016
    Report Date
    December 7, 2016
    Manufacturer
    NUVASIVE, INC.
    Product Code
    NKB
    UDI-DI
    00887517594204
    PMA / PMN Number
    K132014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANT WAS DISCARDED BY USER FACILITY AND UNAVAILABLE FOR EXAMINATION. IT IS UNKNOWN IF THE PATIENT SUSTAINED AN IMPACT OR FALL. RADIOLOGIC FILMS SHOWED A VERY LARGE CONSTRUCT WITH AN ACUTE EXTREME LORDOTIC BEND AT THE FRACTURE POINT. THIS BEND MAY HAVE CONTRIBUTED TO THE FRACTURE EVENT DUE TO THE LENGTH AND EXTREME BENDS WHICH RESULT IN HIGH PRELOAD CONDITIONS AND SUBSEQUENT MATERIAL FATIGUE. LABELING REVIEW: "...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." "...CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. THE POTENTIAL FOR SUCCESS IS INCREASED BY THE SELECTION OF THE PROPER SIZE OF THE IMPLANT. WHILE PROPER SELECTION CAN MINIMIZE RISKS, THE SIZE AND SHAPE OF HUMAN BONES PRESENT LIMITATIONS ON THE SIZE AND STRENGTH OF IMPLANTS. METALLIC AND INTERNAL FIXATION DEVICES CANNOT WITHSTAND THE ACTIVITY LEVELS AND/OR LOADS EQUAL TO THOSE PLACED ON NORMAL, HEALTHY BONE. THESE DEVICES ARE NOT DESIGNED TO WITHSTAND THE UNSUPPORTED STRESS OF FULL WEIGHT OR LOAD BEARING ALONE." "... LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND BY THE PATIENT'S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE IMPLANT." PATIENT EDUCATION: "...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 POST-OPERATIVE 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." DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE. ON (B)(6) 2016 A REVISION PROCEDURE TOOK PLACE TO REPLACE A FRACTURED ROD AT L4/5. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806247 GSB GLOBAL SPINAL BALANCE SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB NUVASIVE, INC. 15455500 00887517594204

    Patients

    Seq Age Sex Outcome Treatment
    1