BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1013723 · Received March 13, 2008

    Report

    Report Number
    1030489-2008-00130
    Event Type
    Injury
    Date Received
    March 13, 2008
    Report Date
    January 1, 2001
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    KWQ
    PMA / PMN Number
    K970806
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED TO THE MFR FOR EVAL. THE SCREW BREAKAGE WAS CONFIRMED. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT AN ACDF AT C4-C6 USING ALLOGRAFT WITH ANTERIOR FIXATION. ONE OF THE C6 SCREWS REPORTEDLY BACKED OUT DUE TO NONUNION OF C5-C6 AT UNK TIME POST OP. THE SCREW ON THE OPPOSITE SIDE REPORTEDLY HAD A FRACTURE. THE REVISION SURGERY WAS PERFORMED TO REMOVE THE CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM BONE SCREW KWQ WARSAW ORTHOPEDIC INC NA 08920

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKI