BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 19130593 · Received April 18, 2024

    Report

    Report Number
    2135156-2024-00003
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    March 18, 2024
    Report Date
    April 17, 2024
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    OQB
    UDI-DI
    M74002270050
    PMA / PMN Number
    K230927
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OF ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO AN INJURY OR DEATH.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT AN INTERBODY FUSION PROCEDURE WITH PLACEMENT OF AN INTERBODY FUSION DEVICE ON (B)(6) 2024. DURING THE SURGICAL PROCEDURE, UPON REACHING SIGNS OF IMPLANT FULLNESS, THE DISTAL TIP OF A BONE FILL TUBE WAS SHEARED OFF WHILE BEING FORCIBLE WITHDRAWN FROM THE ACCESS TUBE. THE LOOSE FRACTURED BONE TUBE TIP WAS SUBSEQUENTLY OBSERVED IN THE CENTRAL CANAL OF THE SPINE. A SEPARATE INCISION AND DECOMPRESSION WAS NECESSARY TO REMOVE THE METAL FRAGMENT FROM THE SPINAL CANAL. FOLLOWING THE PROCEDURE, THE PATIENT HAS NO CLINICAL ISSUES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539458 OPTIMESH BONE VOID FILLER OQB SPINEOLOGY INC. T24003 M74002270050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention