BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHORELINE RT

    MDR report key: 17623449 · Received August 25, 2023

    Report

    Report Number
    3012120772-2023-00027
    Event Type
    Injury
    Date Received
    August 25, 2023
    Report Date
    August 25, 2023
    Manufacturer
    SEASPINE, INC
    Product Code
    ODP
    UDI-DI
    10889981164225
    PMA / PMN Number
    K183083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS INITIALLY REPORTED ON (B)(6). THIS REPORT IS BEING SUBMITTED TO PROVIDE THE INFORMATION OF THE 85-6707-SP INTERBODY, 20X15X7MM, 7 DEGREE, RT INVOLVED IN THE EVENT. THE CONTRIBUTORS TO THE ROOT CAUSE ARE AS FOLLOWS: THE FAILURE ON THE LOCKING COVER SIDE WAS LIKELY CAUSED BY THE STRIPPED THREADS ON THE SPACER, WHICH PREVENTED THE LOCKING COVER FROM ACHIEVING PROPER ENGAGEMENT AFTER FIXATION. ON THE SCREW PORTION OF THE FAILURE, THE LOSS OF BONE INTEGRITY FROM THE RE-TRAJECTORY AT THAT SCREW LOCATION WOULD HAVE CONTRIBUTED TO THE DIFFICULTY.  FIRST, LIKE THE STRIPPED THREADS ON THE SPACER, CREATE A SITUATION THAT WOULD PREVENT THE SCREW FROM ACHIEVING THE OPTIMAL TAPPING/THREADING INTO THE BONE. ALSO, THE LACK OF OVERALL HEIGHT AVAILABLE IN THE COLLAPSED VERTEBRAL BODY LIMITS THE CHOICES AVAILABLE FOR BOTH SCREW DEPTH & ANGULATION DURING FIXATION INTO THE VERTEBRAL BODY. REVIEW OF LABELING (IFU): POSSIBLE ADVERSE EVENTS LIKE OTHER SPINAL SYSTEM IMPLANTS, THE FOLLOWING ADVERSE EVENTS ARE POSSIBLE. THIS LIST IS NOT EXHAUSTIVE: DELAYED UNION OR NONUNION (PSEUDARTHROSIS). 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. LOSS OF PROPER SPINAL CURVATURE, CORRECTION, HEIGHT, AND/OR REDUCTION. POSTOPERATIVE FRACTURE DUE TO TRAUMA, DEFECTS, OR POOR BONE STOCK.

    Description of Event or Problem · 0

    THIS EVENT WAS INITIALLY REPORTED ON (B)(6). THIS REPORT IS BEING SUBMITTED TO PROVIDE THE INFORMATION OF THE 85-6707-SP INTERBODY, 20X15X7MM, 7 DEGREE, RT INVOLVED IN THE EVENT. SEASPINE WAS MADE AWARE ON (B)(6) 2023 THAT A PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE' S SHORELINE SYSTEM. THE INDEX SURGERY TOOK PLACE ON (B)(6) 2022. THE X-RAY PROVIDED APPEARS TO SHOW THAT A SCREW LOOSENED POST-OPERATIVELY. ON (B)(6) 2023 THE REPORTER NOTED THAT AT THE 3-MONTH CHECKUP, THE SCREW HAD STARTED TO BACK OUT ALREADY AS OBSERVED ON A LATERAL X-RAY. AT A SUBSEQUENT CHECKUP ABOUT A MONTH AGO THE SURGEON OBSERVED THAT THE SCREW HAD BECOME COMPLETELY DISASSOCIATED WITH THE REST OF THE CONSTRUCT. THE REPORTER ADDED THAT THE CONSTRUCT SPAN FROM C5-C7. THE C5 AND C6 VERTEBRAL BODIES BOTH APPEAR TO HAVE SOME COLLAPSE TO THEM. THEY APPEAR TO BE MUCH SHORTER IN HEIGHT THAN THE ADJACENT LEVELS, MAKING THEM WONDER ABOUT BONE QUALITY. ALSO, DURING THE PROCEDURE THE RESIDENT TOOK A TRAJECTORY INTO C6 THAT DR. LENNARSON DIDN'T LIKE SO HE REVISED A COUPLE OF SCREWS DURING THE INDEX PROCEDURE. A REVISION SURGERY THEN TOOK PLACE ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282776 SHORELINE RT INTERBODY, 20X15X7MM, 7 DEGREE, RT ODP SEASPINE, INC 85-6707 AU1081104F 10889981164225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 3-HOLE PLATE, LOCKING COVER, INTERBODY, SCREWS.