BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEBRAL BODY SPREADER - ANGLED

    MDR report key: 18642323 · Received February 2, 2024

    Report

    Report Number
    MW5151067
    Event Type
    Injury
    Date Received
    February 2, 2024
    Date of Event
    December 6, 2023
    Report Date
    February 1, 2024
    Manufacturer
    CENTINEL SPINE LLC.
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023 DURING THE PROCEDURE THE RATCHET LOCK ON THE SPREADERS WOULD NOT HOLD, MAKING IT DIFFICULT FOR THE SURGEON TO RELEASE THE PLL (POSTERIOR LONGITUDINAL LIGAMENT). THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085976 VERTEBRAL BODY SPREADER - ANGLED PROSTHESIS, INTERVERTEBRAL DISC MJO CENTINEL SPINE LLC. PDL114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown