BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEASPINE SPACER SYSTEM - HOLLYWOOD VI NANOMETALENE

    MDR report key: 12055368 · Received June 23, 2021

    Report

    Report Number
    3012120772-2021-00059
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 22, 2021
    Manufacturer
    SEASPINE, INC.
    Product Code
    MAX
    UDI-DI
    00889981064603
    PMA / PMN Number
    K201193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE 34-9110-S HOLLYWOOD VI NM IMPLANT, 11X30X10,8 DEG, STERILE WAS RETURNED FOR EVALUATION AND THE EVALUATION IS ONGOING AT THE TIME OF THIS REPORT. ON (B)(6) 2021, THE IMPLANT WAS PLACED AND IN USE WITH GLOBUS KINEXXX BONE GRAFT. ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED DUE TO A NON-UNION. UPON REMOVAL OF THE CAGE THAT WAS PLACED (B)(6) 2021, FLAKING WAS OBSERVED FROM THE IMPLANT. INITIAL OBSERVATION OF THE IMPLANT NOTED DEEP TOOL MARKS THAT WOULD OCCUR WHEN REMOVING THE IMPLANT. FURTHER EVALUATION OF THE IMPLANT IN REGARD TO THE REPORT OF NON-UNION IS ONGOING. EVALUATION HAS NOT ARRIVED AT A CONCLUSION AS OF THE TIME OF THIS REPORT. THERE WAS NO LOT NUMBER PROVIDED BY THE REPORTER AND NO LEGIBLE LOT NUMBER ON THE IMPLANT. 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

    ON (B)(6) 2021, THE PATIENT UNDERWENT SPINAL SURGERY CONSISTING OF SEASPINE'S INTERVERTEBRAL FUSION DEVICE HOLLYWOOD VI NANOMETALENE AND GLOBUS' KINEX BONE GRAFT. ON (B)(6) 2021, SEASPINE WAS INFORMED OF A REVISION SURGERY DUE TO PSEUDARTHROSIS. IT WAS REPORTED THAT THE SAME DEVICES WERE IMPLANTED IN THE ADJACENT LEVEL WHICH FUSED AS INTENDED. ADDITIONALLY, UPON REMOVAL OF THE HOLLYWOOD VI NANOMETALENE INTERBODY, IT WAS OBSERVED THAT PORTIONS OF THE NANOMETALENE COATING WAS REMOVED FROM THE PEEK INTERBODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944036 SEASPINE SPACER SYSTEM - HOLLYWOOD VI NANOMETALENE 34-9110-S HOLLYWOOD VI NM IMPLANT, 11X30X10,8 DEG, STERILE MAX SEASPINE, INC. 34-9110-S 00889981064603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention