BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEASPINE SKIPJACK SYSTEM

    MDR report key: 10463595 · Received August 27, 2020

    Report

    Report Number
    3012120772-2020-00065
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    July 17, 2020
    Report Date
    August 27, 2020
    Manufacturer
    SEASPINE INC.
    Product Code
    MAX
    UDI-DI
    10889981155100
    PMA / PMN Number
    K193418
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SKIPJACK IMPLANT WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, BASED ON THE X-RAY PROVIDED, THE IMPLANT SUBSIDED INTO THE L2 AND L3 VERTEBRAL BODIES. FURTHERMORE, THERE IS NO INDICATION THAT THE SKIPJACK INTERBODY COLLAPSED OR FRACTURED IN-SITU. THE CONSTRUCT WAS EXTENSIVE, AND NOTED SKIPJACK INTERBODY DEVICES AT FOUR LUMBAR SPINE LEVELS, CONSTITUTING OFF-LABEL PRODUCT USAGE. REVIEW OF LABELING: POSSIBLE ADVERSE EVENTS: LIKE OTHER SPINAL SYSTEM IMPLANTS, THE FOLLOWING ADVERSE EVENTS ARE POSSIBLE. THIS LIST IS NOT EXHAUSTIVE: DELAYED UNION OR NONUNION (PSEUDARTHROSIS) 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, DISCOMFORT, OR ABNORMAL SENSATIONS DUE TO THE PRESENCE OF THE DEVICE PRESSURE ON SKIN WHERE INADEQUATE TISSUE COVERAGE EXISTS OVER THE IMPLANT, WITH POTENTIAL EXTRUSION THROUGH THE SKIN. DURAL LEAK REQUIRING SURGICAL REPAIR. CESSATION OF GROWTH OF THE FUSED PORTION OF THE SPINE. SUBSIDENCE OF THE IMPLANT INTO ADJACENT BONE. LOSS OF PROPER SPINAL CURVATURE, CORRECTION, HEIGHT AND/OR REDUCTION. INCREASED BIOMECHANICAL STRESS ON ADJACENT LEVELS. IMPROPER SURGICAL PLACEMENT OF THE IMPLANT CAUSING STRESS SHIELDING OF THE GRAFT OR FUSION MASS. INTRAOPERATIVE FISSURE, FRACTURE, OR PERFORATION OF THE SPINE. POSTOPERATIVE FRACTURE DUE TO TRAUMA, DEFECTS, OR POOR BONE STOCK. SERIOUS COMPLICATIONS ASSOCIATED WITH ANY SURGERY MAY OCCUR. THESE INCLUDE, BUT ARE NOT LIMITED TO: WOUND COMPLICATIONS, INFECTION, GENITOURINARY DISORDERS, GASTROINTESTINAL DISORDERS, VASCULAR DISORDERS, INCLUDING THROMBUS; BRONCHOPULMONARY DISORDERS, INCLUDING EMBOLI; BURSITIS, HEMORRHAGE, MYOCARDIAL INFARCTION, PARALYSIS OR DEATH.

    Description of Event or Problem · 1

    UPON REVIEW OF RETURNED SEASPINE MARINER EXPLANTS (REF REPORT #3012120772-2020-00060) ON 28 JUL 2020, SEASPINE DISCOVERED THAT A SEASPINE SKIPJACK INTERBODY HAD SUBSIDED. A REVISION SURGERY OCCURRED ON (B)(6) 2020, WHICH CONSISTED OF REPLACING THE INTERBODY AT L2/L3 IN ADDITION TO REPLACING (4) SCREWS AT S1 AND S2AL AND REINSTRUMENTING THE ENTIRE CONSTRUCT WITH NEW SET SCREWS. ON (B)(6) 2020, SEASPINE WAS INFORMED OF THE PATIENT'S DEATH. THERE IS NO INFORMATION THAT SUGGESTS THE DEATH OF THE PATIENT IS RELATED TO THE USE OF A SEASPINE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925720 SEASPINE SKIPJACK SYSTEM SKIPJACK IMPLANT MAX SEASPINE INC. 41-1010 10889981155100

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention