BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 7465104 · Received April 26, 2018

    Report

    Report Number
    3005525032-2018-00030
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    March 28, 2018
    Report Date
    June 21, 2018
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    UDI-DI
    04546540560193
    PMA / PMN Number
    K113666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED EVENT WAS CONFIRMED VIA CORRESPONDENCE. THE DEVICE WAS DISCARDED AT THE HOSPITAL, SO DEVICE INSPECTION COULD NOT BE PERFORMED. NO LOT NUMBER WAS PROVIDED, SO A MANUFACTURING RECORD REVIEW COULD NOT BE COMPLETED. CONCLUSION: PER WHAT WAS REPORTED, NOT STRYKER PRODUCT WAS USED TO TIGHTEN THE BLOCKER. ACCORDING TO THE IFU, "STRYKER SPINE IMPLANTS MAY ONLY BE IMPLANTED WITH THE APPROPRIATE INSTRUMENTS SUPPLIED BY STRYKER SPINE. STRYKER SPINE SHALL NOT BE LIABLE FOR IMPLANTS IMPLANTED USING OTHER MANUFACTURER¿S INSTRUMENTS." THE MOST LIKELY ROOT CAUSES ARE DEVIATION FROM THE SURGICAL TECHNIQUE BY USING A NON STRYKER SPINE TORQUE WRENCH AND POSSIBLY MISALIGNMENT OF THE BLOCKERS DURING TIGHTENING. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED HOWEVER AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TULIP HEAD ON THE SCREWS WAS LOOSE AND WOULD NOT TAKE A BLOCKER. ONE OF THE BLOCKERS THAT WAS TRIED, WAS SEVERED AT AN ANGLE. THE TWO SCREWS WERE TAKEN OUT AND REPLACED. THERE WAS A 30 MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TULIP HEAD ON THE SCREWS WAS LOOSE AND WOULD NOT TAKE A BLOCKER. ONE OF THE BLOCKERS THAT WAS TRIED, WAS SEVERED AT AN ANGLE. THE TWO SCREWS WERE TAKEN OUT AND REPLACED. THERE WAS A 30 MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310018 XIA 3 TITANIUM BLOCKER THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US 48230000 NA 04546540560193

    Patients

    Seq Age Sex Outcome Treatment
    1