BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARINER PEDICLE SCREW SYSTEM

    MDR report key: 10411326 · Received August 14, 2020

    Report

    Report Number
    3012120772-2020-00060
    Event Type
    Death
    Date Received
    August 14, 2020
    Date of Event
    July 17, 2020
    Report Date
    August 14, 2020
    Manufacturer
    SEASPINE INC.
    Product Code
    NKB
    UDI-DI
    10889981155100
    PMA / PMN Number
    K173882
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANT WITNESS MARKS ARE CONSISTENT WITH APPLICATION OF EXPECTED TORQUE LEVELS; ASSOCIATED INSTRUMENTATION WAS NOTED TO BE WITHIN ESTABLISHED SPECIFICATIONS. ADDITIONAL MARKS ARE CONSISTENT WITH PROGRESSIVE LOOSENING. THE TOP THREAD OF TWO SET SCREWS EXHIBITED DAMAGE CONSISTENT WITH FORCEFUL SEPARATION; THE CORRESPONDING THREAD FORM OF THE MATING COMPONENT EXHIBITED ANALOGOUS DAMAGE . THIS IS CONSISTENT WITH THE REPORT THAT THE PATIENT HAD SUSTAINED A FALL. ASSOCIATED RODS WERE NOTED TO HAVE DEFLECTED 20-30MM FROM SCREW HEAD AFTER SET SCREW SEPARATION, THUS ALTERING THE PATIENT'S SPINAL ALIGNMENT. REVIEW OF THE SURGICAL EVENTS INDICATES APPROPRIATE TECHNIQUE WITH THE EXCEPTION OF FINAL TIGHTENING RE-ASSESSMENT FOLLOWING SPINAL ALIGNMENT PROCEDURES AS IS A GENERAL PRACTICE RECOMMENDED BY DEFORMITY SURGEONS. 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, 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 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, RESPIRATORY DISORDERS; CARDIOVASCULAR DISORDERS, INCLUDING MYOCARDIAL INFARCTION (HEART ATTACK) OR ARRYTHMIAS; NEUROLOGIC INJURIES RESULTING IN WEAKNESS, PARALYSIS, NUMBNESS, TINGLING, OR PAIN; VASCULAR (BLOOD VESSEL) INJURIES, HEMORRHAGE (BLEEDING); THROMBOSIS (BLOOD CLOTS) LEADING TO DEEP VENOUS THROMBOSIS OR PULMONARY EMBOLISM, OR DEATH. WARNINGS AND PRECAUTIONS PATIENTS WITH PREVIOUS SPINAL SURGERY AT THE LEVEL(S) TO BE TREATED MAY HAVE DIFFERENT CLINICAL OUTCOMES COMPARED TO THOSE WITHOUT PREVIOUS SURGERY. THE SAFETY AND EFFECTIVENESS OF SPINAL SYSTEMS HAVE BEEN ESTABLISHED ONLY FOR SPINAL CONDITIONS WITH SIGNIFICANT MECHANICAL INSTABILITY OR DEFORMITY REQUIRING FUSION WITH INSTRUMENTATION. THESE CONDITIONS ARE SIGNIFICANT MECHANICAL INSTABILITY OR DEFORMITY OF THE SPINE SECONDARY TO SEVERE SPONDYLOLISTHESIS, DEGENERATIVE SPONDYLOLISTHESIS WITH OBJECTIVE EVIDENCE OF NEUROLOGICAL IMPAIRMENT, FRACTURE, DISLOCATION, SCOLIOSIS, KYPHOSIS, SPINAL TUMOR AND FAILED PREVIOUS FUSION (PSEUDARTHROSIS). THE SAFETY AND EFFECTIVENESS OF THESE DEVICES FOR ANY OTHER CONDITION IS UNKNOWN. THE IMPLANTATION OF THIS SYSTEM SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS DEVICE BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT. THE SURGEON SHOULD CONSIDER THE LEVELS OF IMPLANTATION, PATIENT WEIGHT, PATIENT ACTIVITY LEVEL, OTHER PATIENT CONDITIONS, ETC. WHICH MAY IMPACT THE PERFORMANCE OF THE SYSTEM. ENSURE ALL IMPLANTS, COMPONENTS OR INSTRUMENTS ARE STERILIZED PRIOR SURGERY. THE USE OF NON-STERILE DEVICES MAY LEAD TO INFLAMMATION, INFECTION OR DISEASE. IMPLANTS SHOULD NEVER BE REUSED UNDER ANY CIRCUMSTANCES. A USED IMPLANT SHOULD BE DISCARDED. WHILE THE IMPLANT MAY APPEAR UNDAMAGED, IT MAY HAVE SMALL DEFECTS OR INTERNAL STRESS PATTERNS AND IF IMPLANTED, COULD FAIL TO PERFORM AS INTENDED AND POSE SAFETY RISKS TO THE PATIENT. THE RISKS INCLUDE, BUT ARE NOT LIMITED TO, MECHANICAL FAILURE, BREAKAGE, DIFFICULTY WITH IMPLANTATION, INCOMPATIBILITY WITH MATING COMPONENTS AND INFECTION. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SPINAL SURGERY ON (B)(6) 2020 CONSISTING OF SEASPINE'S MARINER PEDICLE SCREW SYSTEM. SEASPINE WAS MADE AWARE ON (B)(6) 2020 THAT QTY (4) SET SCREWS DISASSOCIATED POSTOPERATIVELY, WHICH WAS DISCOVERED AFTER THE PATIENT SUFFERED FROM A FALL, HEARD A POP, AND WAS EXPERIENCING PAIN. DURING REVIEW OF THE X-RAYS PROVIDED, IT WAS ALSO DISCOVERED THAT A SEASPINE SKIPJACK INTERBODY HAD SUBSIDED. A REVISION SURGERY OCCURRED ON (B)(6) 2020, WHICH CONSISTED OF REPLACING THE (4) SCREWS AT S1 AND S2AL AND RE-INSTRUMENTING 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
    873352 MARINER PEDICLE SCREW SYSTEM SET SCREW NKB SEASPINE INC. 41-1010 AW118251D 10889981155100

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| R