BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATOMIC ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 846481 · Received May 7, 2007

    Report

    Report Number
    3004893332-2007-00001
    Event Type
    Injury
    Date Received
    May 7, 2007
    Date of Event
    April 11, 2007
    Report Date
    April 17, 2007
    Manufacturer
    SPINAL ELEMENTS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K060491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MORE THAN ONE SCREW MODEL WAS INVOLVED IN THIS EVENT. ALL SCREWS HAVE THE SAME BRAND NAME, COMMON DEVICE NAME, AND MANUFACTURER. THIS INFORMATION IS LISTED IN THIS FORM. THE MODEL# AND LOT# OF ONE SCREW IS LISTED IN THIS FORM. THE ADDITIONAL SCREW MODEL AND LOT NUMBERS ARE LISTED IN THIS FORM.

    Description of Event or Problem · 1

    THE ATTENDING PHYSICIAN OBSERVED SCREWS BACKING OUT FROM AN ANTERIOR CERVICAL PLATE ON X-RAYS TAKEN DURING A ROUTINE FOLLOW-UP EXAM. HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT DID NOT COMPLY WITH POST-OPERATIVE INSTRUCTIONS. A REVISION SURGERY WAS PERFORMED TO REPLACE SCREWS AND REESTABLISH FIXATION. THAT PATIENT EXPERIENCED NO NEUROLOGICAL SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATOMIC ANTERIOR CERVICAL PLATE SYSTEM KWQ KWQ SPINAL ELEMENTS, INC. 25040-012 060472

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention MODEL # - 25140-012 LOT # 060568| MODEL # - 25145-012 LOT # 060573