BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERWATCH

    MDR report key: 12801095 · Received November 11, 2021

    Report

    Report Number
    3004893332-2021-00017
    Event Type
    Injury
    Date Received
    November 11, 2021
    Date of Event
    April 29, 2021
    Report Date
    November 11, 2021
    Manufacturer
    SPINAL ELEMENTS, INC
    Product Code
    NKB
    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

    THOUGH REVISION SURGERY OCCURRED, THE DEVICE WAS NOT RETURNED. DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, NO EVENT RADIOGRAPHS NOR IMAGES OF THE DEVICE WERE PROVIDED FOR ANALYSIS. TO DATE, MULTIPLE COMMUNICATION ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE PRODUCT INFORMATION AND LOT NUMBER. PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. DHR REVIEW CANNOT BE COMPLETED AT THIS TIME. 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.

    Description of Event or Problem · 0

    AS PART OF A RETROSPECTIVE REVIEW PRESENTATION SPANNING 2019-2021 GIVEN BY AN ORTHOPEDIC MEDICAL GROUP, IT WAS NOTED THAT A PATIENT RECEIVED A PLF WITH BILATERAL POSTERIOR FIXATION FROM L5- S1 ON (B)(6) 2021. THREE MONTHS POST OPERATIVELY THE S1 BONE SCREW HAD FRACTURED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REPLACE THE SCREWS WILL LARGER DIAMETER SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699342 OVERWATCH THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB SPINAL ELEMENTS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male Required Intervention