BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCURY

    MDR report key: 8171122 · Received December 17, 2018

    Report

    Report Number
    3004893332-2018-00006
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 20, 2018
    Report Date
    November 20, 2018
    Manufacturer
    SPINAL ELEMENTS, INC
    Product Code
    NKB
    PMA / PMN Number
    K083230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS EVALUATED AND NO DEVIATIONS OR DISCREPANCIES WERE OBSERVED. RETURNED DEVICE WAS EVALUATED AND THE COMPLAINT WAS CONFIRMED. DEVICE MET SPECIFICATIONS EXCEPT IN THE AREA OF DAMAGE WHICH COULD NOT BE FULLY MEASURED. DEVICE TIP IS FRACTURED OFF. THE MATERIAL DEFORMATION EVIDENCE SUGGESTS THAT THE MATERIAL YIELDED AS A RESULT OF EXCESSIVE FORCES AND POSSIBLE FATIGUE. ROOT CAUSE OR SPECIFIC FAILURE MODE CANNOT BE DETERMINED. LABELING REVIEW NOTES: "INTRAOPERATIVE MANAGEMENT ... BREAKAGE, SLIPPAGE OR MISUSE OF INSTRUMENTS OR IMPLANT COMPONENTS MAY CAUSE PATIENT INJURY ...."

    Description of Event or Problem · 1

    PATIENT HAD EXISTING UNILATERAL HARDWARE RIGHT L4-L5. ON (B)(6) 2018, PATIENT RECEIVED A TWO LEVEL SPINAL FUSION SURGERY L2-L4 WITH BILATERAL POSTERIOR FIXATION L2-L5. DURING FINAL TIGHTENING OF THE CROSS CONNECTOR THE TRANSVERSE CONNECTOR DRIVER TIP FRACTURED OFF AND REMAINED IN THE HEX OF THE CROSS CONNECTOR. THE SURGEON ELECTED TO LEAVE THE TIP IN THE CROSS CONNECTOR IN THE PATIENT. NO PATIENT INJURY WAS REPORTED AND NO REVISION SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012050 MERCURY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB SPINAL ELEMENTS, INC 61215-000 100585

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR