BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TEK IMPLANTS

    MDR report key: 1931417 · Received December 17, 2010

    Report

    Report Number
    2242816-2010-00184
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    EBI, LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL COMPONENT INVOLVED IN EVENTPART NO. DESCRIPTION1100-2016 16MMX4MM VARIABLE SCREW1100-2116 16MMX4.35MM VARIABLE SCREWPER THE IFU, "POSSIBLE ADVERSE EFFECTS INCLUDE, BUT ARE NOT LIMITED TO":"BENDING, LOOSENING OR FRACTURE OF THE IMPLANTS""REOPERATION"

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOCKING PLATE HAS LOOSENED AND IS NOW IN THE 'OPEN' POSITION. ADDITIONALLY, ONE OF THE IMPLANTED SCREWS IS BACKING OUT. PHYSICIAN INDICATES PATIENT IS FUSED BUT WANTS TO REMOVE SCREW AND RE-LOCK PLATE. PATIENT OUTCOME: REVISION SURGERY SCHEDULED. NO ADVERSE EFFECTS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TEK IMPLANTS 43MM 2-LEVEL PLATE KWQ EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1