BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION POLYAXIAL SCREW 6.5X40

    MDR report key: 7686488 · Received July 13, 2018

    Report

    Report Number
    0009617544-2018-00171
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 20, 2018
    Report Date
    October 11, 2018
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    UDI-DI
    07613327351910
    PMA / PMN Number
    K170496
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED EVENT WAS CONFIRMED VIA CORRESPONDENCE WITH THE REPRESENTATIVE. ALL BROKEN FRAGMENTS WERE RETRIEVED, HOWEVER, THE DEVICES ARE UNAVAILABLE FOR EVALUATION AS THEY WERE IMPLANTED. LOT NUMBERS WERE NOT PROVIDED, SO MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED. IT WAS REPORTED THAT THE SURGEON USED AN INAPPROPRIATE INSTRUMENT. FOR INSERTING SCREWS, THE SERRATO SURGICAL TECHNIQUE STATES TO USE THE SERRATO SCREWDRIVER WITH SERRATO SCREWS. THE SCREWDRIVER REPORTEDLY USED IS NOT LISTED IN THE SURGICAL TECHNIQUE AS A SCREWDRIVER TO BE USED WITH SERRATO SCREWS. THE XIA II SCREWDRIVER HAS A DIFFERENT TIP THAT MATES WITH THE XIA II SCREW INTERFACE, WHICH USES A 4 POINT DESIGN AS OPPOSED TO A 6 POINT DESIGN. THIS INSTRUMENT IS NOT COMPATIBLE WITH THE SERRATO SYSTEM. IN ADDITION, THE SURGEON APPEARED TO APPLY EXCESSIVE FORCE AS THEY USED AN INSTRUMENT OF THE OTHER TECHNIQUE, AND IT WASN'T ALIGNED AND THE ANGLE WAS INAPPROPRIATE. CONCLUSION: THE MOST LIKELY ROOT CAUSE IS USER ERROR AS AN INCOMPATIBLE SCREWDRIVER WAS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSERTION OF THE ROD INTO THE SCREWS, THE HEAD OF THE SCREWS BROKE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION OF THE ROD INTO THE SCREWS, THE HEAD OF THE SCREWS BROKE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530324 REDUCTION POLYAXIAL SCREW 6.5X40 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US UNKNOWN 07613327351910

    Patients

    Seq Age Sex Outcome Treatment
    1