BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUINTEX SEMICONSTRAINED SCREW 4.0X14MM

    MDR report key: 4231798 · Received October 15, 2014

    Report

    Report Number
    3005673311-2014-00072
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    July 23, 2014
    Report Date
    September 2, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    KWQ
    PMA / PMN Number
    K100243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MANUFACTURING SITE EVALUATION: THE SCREW DISPLAYS NO MECHANICAL DEFECTS. THE LOCKING RINGS DISPLAY NO DAMAGE OR INDICATIONS OF MANUFACTURING ISSUES. THE PEDICLES ARE NOT BENT AND ARE EVENLY SPACED. IT IS LIKELY THAT THE SCREWDRIVER WAS APPOINTED AND/OR DRIVEN AT AN INCORRECT ANGLE. THE MANUFACTURING DOCUMENTS WERE CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION DURING THE TIME OF PRODUCTION. THERE ARE NO OTHER COMPLAINTS FOR THIS BATCH NUMBER. NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). WITH THE INSERTION OF TWO SCREWS, THE INTERLOCKING RINGS DISMOUNTED. ONE SCREW WAS LEFT IN PLACE WITHOUT THE LOCKING RING PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652830 QUINTEX SEMICONSTRAINED SCREW 4.0X14MM BONE SCREW KWQ AESCULAP AG & CO. KG SC502T 52032943

    Patients

    Seq Age Sex Outcome Treatment
    1 Other