BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGATTA LATERAL INSERTER

    MDR report key: 19361804 · Received May 21, 2024

    Report

    Report Number
    3012120772-2024-00013
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 21, 2024
    Manufacturer
    SEASPINE, INC
    Product Code
    MAX
    UDI-DI
    10889981162306
    PMA / PMN Number
    K201193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE 36-90-3000 REGATTA LATERAL INSERTER WAS RETURNED AND EVALUATED BY PRODUCT ENGINEERS. THE INSERTER TIP HAD SHEARED OFF, POSSIBLY DUE TO OVER-TIGHTENING OF THE IMPLANT. THE FRACTURED TIP REMAINS IN THE IMPLANT. NO RADIOGRAPHS WERE PROVIDED. REVIEW OF LABELING: INTRAOPERATIVE WARNINGS BREAKAGE, SLIPPAGE, OR MISUSE OF INSTRUMENTS OR IMPLANT COMPONENTS MAY CAUSE INJURY TO THE PATIENT OR OPERATIVE PERSONNEL.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S REGATTA LATERAL SYSTEM. THE 36-90-3000 REGATTA LATERAL INSERTER FRACTURED INTRA-OPERATIVELY AND THE FRAGMENT WAS LEFT INSIDE THE PATIENT. THE CUSTOMER REPORTED THAT THE SURGERY WAS COMPLETED, AND NO ADDITIONAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156463 REGATTA LATERAL INSERTER LATERAL IMPLANT INSERTER MAX SEASPINE, INC 36-90-3000 CR48577CR2 10889981162306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other