BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7693327 · Received July 17, 2018

    Report

    Report Number
    1030489-2018-01010
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 20, 2018
    Report Date
    October 3, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KQW
    PMA / PMN Number
    K102807
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: LUMBAR SPINAL CANAL STENOSIS PROCEDURE: TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) LEVELS IMPLANTED: L3/4/5 IT WAS REPORTED THAT ON (B)(6) 2018, INTRA-OP, THE SCREWS WERE INSERTED WITHOUT PROBLEM AT FIRST, AND 4MM REDUCTION SCREW WAS PLACED ONLY FOR L3. THERE WAS ALSO NO PROBLEM WITH INSERTING THE ROD, AND IT WAS PLACED ON L4/5 UNTIL "RD" AND PROVISIONAL FIXATION WAS PERFORMED, AND THERE WAS NO PROBLEM WITH THE PROVISIONAL FIXATION ON THE LEFT SIDE. THE PROVISIONAL FIXATION WAS PERFORMED ON THE RIGHT SIDE OF L4, AND WHEN L5 SET SCREW WAS ATTEMPTED TO BE INSERTED, THE SITUATION WAS THAT IT COULD NOT BE TIGHTENED UNTIL THE END ALTHOUGH IT GRIPPED IN THE MIDDLE. WHEN THE SET SCREW WAS CHECKED, IT WAS CONFIRMED THAT IT WAS GOUGED. NO MATTER HOW MANY TIMES THE SURGEON TRIED WITH NEW SET SCREWS, THERE WAS NO EFFECT. IT WAS SUSPECTED THAT THERE MIGHT BE SOMETHING WRONG WITH THE SCREW HEAD. THEREFORE, THE SCREW WAS REMOVED AND REPLACED WITH A NEW SCREW, AND THE NEW SCREW WAS INSERTED AGAIN. THE ROD WAS PLACED AND THE PROVISIONAL FIXATION WAS ATTEMPTED TO BE PERFORMED, BUT IT COULD NOT BE PERFORMED AGAIN ON THE RIGHT SIDE OF L5. WHEN CHECKING IT BY IMAGE, IT WAS OBVIOUS THAT THE EXTENDER WAS DISENGAGED, SO THE SCREW WAS REMOVED AGAIN. AS THERE WAS A BACKUP EXTENDER, THIS ONE WAS USED INSTEAD, AND THEN THERE WAS NO PROBLEM WITH THE TIGHTENING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535199 CD HORIZON SPINAL SYSTEM GONIOMETER, NONPOWERED KQW MEDTRONIC SOFAMOR DANEK USA, INC NA RS11M037

    Patients

    Seq Age Sex Outcome Treatment
    1