BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAL SPINAL SYSTEM

    MDR report key: 10480444 · Received September 1, 2020

    Report

    Report Number
    3012120772-2020-00068
    Event Type
    Injury
    Date Received
    September 1, 2020
    Date of Event
    August 1, 2020
    Report Date
    September 1, 2020
    Manufacturer
    SEASPINE INC.
    Product Code
    NKB
    UDI-DI
    10889981030209
    PMA / PMN Number
    K120047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE 10-23-0130 INLINE CONNECTORS WERE RETURNED FOR INVESTIGATION AND EVALUATED ON 25 AUG 2020. THE SET SCREW COMPONENTS OF THE CONNECTORS WERE NOT MADE AVAILABLE FOR ANALYSIS AS THEY WERE DISCARDED BY THE HOSPITAL. UPON REVIEW OF THE RETURNED CONNECTORS, NO VISIBLE DAMAGE IS NOTED ON THE CONNECTOR BODIES TO INDICATE HOW A FAILURE MAY HAVE OCCURRED OR THAT THE CAUSE IS RELATED TO THE PRODUCT. THE RADIOGRAPH PROVIDED CONFIRMS THE RIGHT CONNECTOR SLIPPED ON THE ROD, POTENTIALLY AS A RESULT OF THE REPORTED LOOSENED OR DISASSOCIATED SET SCREW. ADDITIONALLY, THE TORQUE HANDLE USED TO FINAL TIGHTEN THE CONNECTORS WAS FUNCTIONALLY TESTED, MEASURED, AND FOUND TO BE WITHIN SPECIFICATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE TORQUE HANDLE WAS FOUND TO BE WITHIN SPECIFICATION, THE CONNECTOR BODIES DO NOT DISPLAY ANY INDICATION OF FAILURE OR DAMAGE, AND THE SET SCREWS WERE NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE MAY BE RELATED TO SURGICAL TECHNIQUE: SYSTEM OVER-TORQUED OR CROSS-THREADING OF THE SET SCREW UPON INSERTION. REVIEW OF LABELING: POSSIBLE ADVERSE EVENTS BENDING, DISASSEMBLY OR FRACTURE OF IMPLANT AND COMPONENTS LOOSENING OF SPINAL FIXATION IMPLANTS MAY OCCUR DUE TO INADEQUATE INITIAL FIXATION, LATENT INFECTION, AND/OR PREMATURE LOADING, POSSIBLY RESULTING IN BONE EROSION, MIGRATION OR PAIN.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SPINAL SURGERY ON (B)(6) 2020 CONSISTING OF SEASPINE'S THORACOLUMBOSACRAL PEDICLE SCREW CORAL SPINAL SYSTEM. THE PATIENT REPORTED THAT THE HARDWARE WAS "SQUEAKING" POSTOPERATIVELY, WHICH PROMPTED A REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2020 TO REPLACE BOTH PREVIOUSLY IMPLANTED CORAL INLINE CONNECTORS. IT WAS REPORTED THAT AT THE TIME OF REVISION, THE SURGEON FOUND THAT THE CAUDAL SCREW ON THE RIGHT INLINE CONNECTOR WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942359 CORAL SPINAL SYSTEM INLINE CONNECTOR, 5.5MM TO 5.5MM NKB SEASPINE INC. 10-23-0130 10889981030209

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention