BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST® SPINAL SYSTEM

    MDR report key: 8321451 · Received February 8, 2019

    Report

    Report Number
    3004774118-2019-00008
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    January 15, 2019
    Report Date
    April 29, 2020
    Manufacturer
    K2M, INC.
    Product Code
    NKB
    PMA / PMN Number
    K133944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL, DIMENSIONAL, MATERIAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. DEVICE AND COMPLAINT HISTORY RECORDS REVIEW COULD NOT BE PERFORMED AS A VALID LOT CODE WAS NOT PROVIDED AND COULD NOT BE OBTAINED. FROM THE PROVIDED FLUORO IMAGES, A SET SCREW ON THE BOTTOM RIGHT LEVEL OF THE CONSTRUCT IS LOOSE. THE ROD CAPTURED BY THIS SET SCREW HAS SLIPPED OFF. IT IS POSSIBLE THAT THE SET SCREW IN THE ADJACENT LEVEL HAS LOOSENED AS WELL; HOWEVER, IT CANNOT BE CONFIRMED BASED ON IMAGES. IN THE EVENT THAT A SET SCREW LOOSENS OR DISENGAGES, IT IS POSSIBLE THAT THE SET SCREW MAY HAVE BEEN UNDER TORQUED UPON INDEX SURGERY. IT IS ALSO POSSIBLE THAT THE ROD WAS NOT FULLY SEATED UPON INDEX SURGERY. EITHER OF THE LATTER SITUATIONS MAY HAVE CAUSED THE CAPTURE STRENGTH OF THE SET SCREW/ TULIP LOCKING MECHANISM TO WEAKEN UPON LOADING AND DYNAMIC MOTION OVER THE 4 TO 6-MONTH TIME PERIOD. A WEAKENED LOCKING MECHANISM COULD HAVE LED TO THE SET SCREW LOOSENING FROM THE TULIP. THE ROD SLIPPAGE COULD HAVE RESULTED FROM THE WEAKENED CAPTURE MECHANISM. HOWEVER, AS THE PARTS WERE NOT AVAILABLE, THE SET SCREWS COULD NOT BE INSPECTED TO REACH A CONCLUSIVE ROOT CAUSE. NO VISUAL ABNORMALITIES CAN BE SEEN IN EVEREST POLYAXIAL SCREWS IN THE FLUORO IMAGES PROVIDED. B.4. CORRECTED FROM SCREW FRACTURE TO SET SCREW BACKOUT. B.5. CORRECTED TO REFLECT THAT SET SCREWS BACKED OUT. D4. FROM CATALOG # 2911-07550 TO 2901-10001 AND UPDATED TO APPROPRIATE UDI#.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED THAT 2 EVEREST ATR SET SCREWS BACKED-OUT, LOOSENED, DISENGAGED APPROXIMATELY 4 TO 6 MONTHS POSTOPERATIVELY. THE SET SCREWS ARE RETAINED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2019 IT WAS REPORTED TO K2M, INC. THAT A SCREW BACKED-OUT, LOOSENED, DISENGAGED APPROXIMATELY 4 TO 6 MONTHS POST-OPERATIVELY. THE SCREW IS RETAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113131 EVEREST® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB K2M, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4), LOT UNKNOWN