BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEQUENCE ANTERIOR CERVICAL PLATING SYSTEM

    MDR report key: 3192564 · Received June 19, 2013

    Report

    Report Number
    1833824-2013-00008
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    April 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO PIONEER SURGICAL FOR EVAL, BUT RATHER WAS LOST AT THE HOSPITAL. MEDWATCH WAS FILED BY THE HOSPITAL ON (B)(6) 2013, (B)(4).

    Description of Event or Problem · 1

    TIP OF SCREWDRIVER BROKE OFF ("COLD FUSED") IN THE PLATE FINAL LOCKING MECHANISM. SURGEON WAS PERFORMING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PLATING SYSTEM. SURGEON LEFT THE PIECE IN THE PT BECAUSE THEY BELIEVED THAT IT WILL NOT CAUSE ANY PROBLEMS AND THEREFORE, DOES NOT NEED TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279260 CEQUENCE ANTERIOR CERVICAL PLATING SYSTEM ANTERIOR CERVICAL PLATING SYSTEM KWQ PIONEER SURGICAL TECHNOLOGY 0259-1001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R