BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUINTEX DYNAMIC SCREW 4.0X12MM

    MDR report key: 3941419 · Received April 16, 2014

    Report

    Report Number
    3005673311-2014-00037
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 15, 2014
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    KWQ
    PMA / PMN Number
    K100243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: VISUAL INSPECTION (MICROSCOPIC): THE SCREW SHOWS NO BENT SEGMENTS. THE DEFECTS ON THE FLANKS INSIDE ARE INDICATIONS THAT THE SCREWDRIVER WAS NOT PROPERLY ATTACHED DURING SCREWING. THE SCREWDRIVER WAS NOT COMPLETELY AND PROPERLY APPOINTED AND OR DRIVEN WITH A WRONG ANGLE. THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATIONS DURING THE TIME OF PRODUCTION. THERE HAVE BEEN NO OTHER COMPLAINTS OF THIS LOT NUMBER. INVOLVED COMPONENT: QUINTEX SCREWDRIVER SC432R SCREWDRIVER SHOWS NO MECHANICAL DEFECTS, FLANKS AND EDGES ARE PROPER. THERE IS NO BURR OR SCORE MARK, SCREWDRIVER IS NOT RELATED TO THE LOCKING RING BEING DETACHED.

    Description of Event or Problem · 1

    ACDF C3 AND C4 / C6 AND C7 ON (B)(6) 2014 TECHNICIAN LOADED THE SCREW; HANDED TO DR. AS SURGEON WAS INSERTING THE SCREW THE RING CAME OUT. THE SCREW WAS NOT ALL THE WAY IN; APPROXIMATELY TWO OR THREE TURNS. SURGEON REMOVED THE SCREW AND LOCKING RING. ANOTHER SCREW WAS LOADED ONTO A DIFFERENT DRIVER AND PLACED WITHOUT INCIDENT. SURGICAL DELAY OF LESS THAN ONE MINUTE. NO PATIENT INJURY. NO ADDITIONAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232159 QUINTEX DYNAMIC SCREW 4.0X12MM TITANIUM-ALLOY PHYNOX SPINE SCREW KWQ AESCULAP AG AND CO. KG SC601T 51958672

    Patients

    Seq Age Sex Outcome Treatment
    1 Other