BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CABO ANTERIOR CERICAL PLATE SYSTEM

    MDR report key: 10299396 · Received July 20, 2020

    Report

    Report Number
    3012120772-2020-00050
    Event Type
    Injury
    Date Received
    July 20, 2020
    Report Date
    July 2, 2020
    Manufacturer
    SEASPINE INC.
    Product Code
    KWQ
    PMA / PMN Number
    K173521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CABO HARDWARE WAS NOT RETURNED FOR INVESTIGATION AND X-RAYS WERE NOT MADE AVAILABLE FOR REVIEW. ADDITIONALLY, LOT NUMBERS WERE NOT PROVIDED; THEREFORE A REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE CONDUCTED. ALL PLATES AND SCREWS ARE REQUIRED TO PASS A FINAL INSPECTION THAT INCLUDES FUNCTIONAL AND DIMENSIONAL TESTING, AND MATERIAL CERTIFICATION PRIOR TO DISTRIBUTION. THE REMOVAL WAS PROMPTED AS A RESULT OF DYSPHAGIA; HOWEVER THE ALLEGATION AND THE ROOT CAUSE CANNOT BE CONFIRMED WITH THE MINIMAL DATA PROVIDED. 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. WARNINGS AND PRECAUTIONS THIS DEVICE IS NOT APPROVED FOR SCREW ATTACHMENT TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE. A SUCCESSFUL RESULT IS NOT ALWAYS ACHIEVED IN EVERY SURGICAL CASE. THIS FACT IS ESPECIALLY TRUE IN SPINAL SURGERY WHERE MANY EXTENUATING CIRCUMSTANCES MAY COMPROMISE THE RESULTS. THE CABO ACP SYSTEM IS ONLY A TEMPORARY IMPLANT USED FOR THE CORRECTION AND STABILIZATION OF THE SPINE. THIS SYSTEM IS ALSO INTENDED TO BE USED TO AUGMENT THE DEVELOPMENT OF A SPINAL FUSION BY PROVIDING TEMPORARY STABILIZATION. THIS DEVICE SYSTEM IS NOT INTENDED TO BE THE SOLE MEANS OF SPINAL SUPPORT. BONE GRAFTING MUST BE PART OF THE SPINAL FUSION PROCEDURE IN WHICH THE CABO ACP SYSTEM IS UTILIZED. USE OF THIS PRODUCT WITHOUT A BONE GRAFT OR IN CASES THAT DEVELOP INTO A NON-UNION WILL NOT BE SUCCESSFUL. THIS SPINAL IMPLANT CANNOT WITHSTAND BODY LOADS WITHOUT THE SUPPORT OF BONE. IN THIS EVENT, BENDING, LOOSENING, DISASSEMBLY AND/OR BREAKAGE OF THE DEVICE(S) WILL EVENTUALLY OCCUR. PREOPERATIVE PLANNING AND OPERATING PROCEDURES, INCLUDING KNOWLEDGE OF SURGICAL TECHNIQUES, PROPER REDUCTION, AND PROPER SELECTION AND PLACEMENT OF THE IMPLANT ARE IMPORTANT CONSIDERATIONS IN THE SUCCESSFUL UTILIZATION OF THE CABO ACP SYSTEM BY THE SURGEON. FURTHER, THE PROPER SELECTION AND COMPLIANCE OF THE PATIENT WILL GREATLY AFFECT THE RESULTS. PATIENTS WHO SMOKE HAVE BEEN SHOWN TO HAVE AN INCREASED INCIDENCE OF NON-UNIONS. THESE PATIENTS SHOULD BE ADVISED OF THIS FACT AND WARNED OF THIS CONSEQUENCE. OBESE, MALNOURISHED, AND/OR ALCOHOL AND/OR OTHER DRUG ABUSE PATIENTS ARE ALSO NOT GOOD CANDIDATES FOR SPINE FUSION. PATIENTS WITH POOR MUSCLE AND BONE QUALITY AND/OR NERVE PARALYSIS ARE ALSO NOT GOOD CANDIDATES FOR SPINE FUSION. POSTOPERATIVE WARNINGS SURGEONS SHOULD ADVISE PATIENTS REGARDING THE RISKS OF SURGERY AND THE IMPORTANCE OF POST-OPERATIVE COMPLIANCE. THE PATIENT SHOULD BE ADVISED TO LIMIT AND RESTRICT PHYSICAL ACTIVITIES, ESPECIALLY LIFTING AND TWISTING MOTIONS AND ANY TYPE OF SPORT PARTICIPATION. THE PATIENT SHOULD BE ADVISED THAT IMPLANTS MAY BEND, BREAK OR LOOSEN DESPITE RESTRICTION IN ACTIVITY. THE PATIENT SHOULD BE ADVISED TO AVOID MECHANICAL VIBRATIONS THAT MAY LOOSEN THE DEVICE. THE PATIENT SHOULD BE ADVISED NOT TO SMOKE OR CONSUME ALCOHOL DURING RECOVERY.

    Description of Event or Problem · 1

    ON (B)(6) 2020, SEASPINE WAS INFORMED OF A SCHEDULED REMOVAL OF CABO ANTERIOR CERVICAL PLATE HARDWARE PER THE PATIENT'S REQUEST DUE TO DYSPHAGIA. THE REMOVAL DATE COULD NOT BE CONFIRMED; HOWEVER, BASED ON THE INFORMATION MADE AVAILABLE TO SEASPINE, THE REMOVAL TOOK PLACE WITHOUT EVENT BETWEEN (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758197 CABO ANTERIOR CERICAL PLATE SYSTEM CABO SCREW KWQ SEASPINE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention