BEUDAMED
    FDA Adverse Event Death Summary report: N

    KRD1 PEDICLE SCREW SYSTEM

    MDR report key: 2818433 · Received October 31, 2012

    Report

    Report Number
    3005977257-2012-00014
    Event Type
    Death
    Date Received
    October 31, 2012
    Date of Event
    August 15, 2011
    Report Date
    October 24, 2012
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD SEVERE STENOSIS OF THE SPINE AND SCOLIOSIS, WITH THE CURVATURE DRASTIC ENOUGH TO CREATE AN EXTREMELY DIFFICULT SURGERY. THE SURGEON WAS ABLE TO SUCCESSFULLY PLACE THE SCREWS AND RODS TO CORRECT THE STENOSIS, SCOLIOSIS. THE LENGTHY SURGERY WAS DUE TO THE TIME NECESSARY TO CORRECT THE DIFFICULT ANATOMY OF THE PATIENT AND THE LONG CLOSE DUE TO THE LONG INCISION (APPROXIMATELY 14 INCHES). IT WAS DETERMINED THAT THE PEDFUSE IMPLANTS AND INSTRUMENTS WERE FUNCTIONING AS INTENDED, AND WERE NOT A CONTRIBUTING FACTOR TO THE CAUSE OF THE DEATH. ACCOMPANYING PHOTOS TAKEN DURING THE SURGERY ARE ATTACHED TO THIS REPORT AND WHICH DEMONSTRATE THE LARGE INCISION AND SEVERE CURVATURE OF THE SPINE OF THE PATIENT. THE LOT HISTORY RECORD OF THE ROD ROCKER WAS REVIEWED. THE INSTRUMENT MET ALL REQUIREMENTS FOR ACCEPTANCE, FREE OF NON-CONFORMITIES. THE PART WAS RETURNED FOR EVALUATION WHICH FOUND THE INSTRUMENT MECHANICALLY SOUND AND ABLE TO PERFORM AS INTENDED.

    Description of Event or Problem · 1

    NOTE: THIS EVENT WAS REVIEWED BY FDA INVESTIGATOR DURING A ROUTINE SURVEILLANCE AUDIT, AND A REQUEST HAS BEEN MADE THAT THIS EVENT BE REPORTED ON A MEDICAL DEVICE REPORT. PREVIOUS PERSONNEL HAD DEEMED THIS A NON-REPORTABLE. THIS EVENT WAS TO BE REPORTED WITHIN 30 DAYS OF OCCURRING. A 12 LEVEL T5-ILIUM FUSION WITH KRD1 PEDFUSE WAS PERFORMED TO TREAT A PATIENT WITH SEVERE STENOSIS AND SCOLIOSIS. DUE TO THE EXTREME DEGREE OF THE SCOLIOSIS DEFORMITY, THE PROCEDURE REQUIRED EXCEPTIONAL FOCUS AND ATTENTION TO THE PATIENT'S ANATOMY BY THE SURGEON IN PLACING THE PEDICLE RODS NEEDED TO STABILIZE THE SPINE. TO CORRECT THE SCOLIOSIS, THE ROD ROCKER INSTRUMENT WAS USED TO MANIPULATE THE PEDICLE ROD TO INSERT INTO THE PEDICLE SCREW. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE PLACEMENT OF THE SCREWS AND ROD ON THE LEFT SIDE OF THE PATIENT. DUE TO THE AMOUNT OF MANIPULATION REQUIRED TO ALIGN THE ROD TO THE SCREW ON THE RIGHT SIDE, THE STRESS INDUCED ONTO THE ROD ROCKER MADE TURNING THE KNOB AT THE PROXIMAL END (USED TO ADJUST THE ROCKING POSITION) DIFFICULT. WHEN INTERVIEWED, THE SURGEON EXPLAINED THE SURGERY REQUIRED METICULOUS CONTROL HOMEOSTASIS AND NECESSITATED A STEADY AND DELIBERATE CONSERVATIVE PACE. THE SURGEON EXPLAINED THAT CAPTURING THE S1 SCREW WAS THE MOST CHALLENGING ANATOMICALLY AND TOOK ALMOST 40 MINUTES TO COMPLETE. HE COULD NOT DELINEATE WHAT AMOUNT OF THAT TIME WAS DUE TO THE DIFFICULT ANATOMY AND WHAT AMOUNT OF TIME WAS DUE TO THE STRESS OF THE INSTRUMENTATION. IT WAS HIS OPINION THAT THE DIFFICULT ANATOMY WAS THE ISSUE. HE STATED THE INSTRUMENT DID PERFORM AND DID SUCCESSFULLY BEND THE ROD TO THE NEEDED SHAPE FOR PLACEMENT. THE SURGERY WAS SUCCESSFUL IN ADDRESSING THE TORTUOUS ANATOMY AND CORRECTING THE SEVERE SCOLIOSIS. THE PATIENT EXPERIENCED BLEEDING POST-OP. (B)(6). THE PATIENT'S FAMILY REFUSED TO ALLOW A BLOOD TRANSFUSION DURING SURGERY OR POST-OPERATIVELY. THE PATIENT PASSED AWAY POST-OPERATIVELY OF CARDIAC ARREST DUE TO TRAUMATIC BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRD1 PEDICLE SCREW SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI SPINEFRONTIER, INC. 11-80031 43211

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death