BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERWATCH

    MDR report key: 12763462 · Received November 7, 2021

    Report

    Report Number
    3004893332-2021-00015
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    October 8, 2021
    Report Date
    November 5, 2021
    Manufacturer
    SPINAL ELEMENTS, INC
    Product Code
    NKB
    UDI-DI
    00840916131852
    PMA / PMN Number
    K161842
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOGRAPH IMAGES CONFIRMED THE COMPLAINT. THOUGH REVISION SURGERY OCCURRED, PATHOLOGY DEPARTMENT WOULD NOT RELEASE DEVICE, AND THE DEVICES WERE NOT RETURNED. UNKNOWN FACTORS INCLUDE: PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, PATIENT BONE QUALITY, THE DEGREE OF SPINAL INSTABILITY, PATIENT COMPLIANCE WITH POST-OPERATIVE CARE INSTRUCTIONS OR IF THE PATIENT SUSTAINED A FALL/IMPACT OF ANY SORT (NO TRAUMA WAS REPORTED.). ROOT CAUSE OR SPECIFIC FAILURE MODE CANNOT BE DETERMINED BUT DURATION TO FAILURE COULD BE A CONTRIBUTING FACTOR.

    Description of Event or Problem · 0

    ON (B)(6) 2021 PATIENT RECEIVED BILATERAL POSTERIOR FIXATION PLF FROM L5- S1. THREE MONTH POST OPERATIVELY RADIOGRAPH DEPICTED BOTH SCREWS AT S1 WERE FRACTURED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656081 OVERWATCH THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB SPINAL ELEMENTS, INC 108-ET-6540C 00840916131852

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention