BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 3021617 · Received March 26, 2013

    Report

    Report Number
    1030489-2013-00860
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 21, 2013
    Report Date
    May 7, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE BREAKAGE OF ONE TIP OF THE LOCKING CAP (THE LOCKING CAP STILL CONNECTED TO THE PLATE) IS CONSISTENT WITH LOAD APPLIED BY ONE OF THE SCREW (PROBABLY THE SCREW BACK-OUT AS DESCRIBED IN THE EVENT). THE BREAKAGE OF THE LOCKING CAP (THE LOCKING CAP "DISCONNECTED" TO THE PLATE) SEEMS TO BE RELATED TO THE STERILIZATION PROCESS STEP AFTER THE REVISION SURGERY AS DESCRIBED IN THE EVENT DESCRIPTION. HOWEVER, THE ROOT CAUSE OF THE BREAKAGE IS UNCLEAR AND CANNOT BE DETERMINED WITH THE PROVIDED INFORMATION. NO DEVIATION OR NON-CONFORMANCE HAS BEEN RECORDED FOR THE PLATE WITH LOT NUMBER W04B2753.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH PLATE IMPLANTATION. AT AN UNKNOWN TIME POST-OP, IT WAS DISCOVERED THAT THE PATIENT HAD PRESSURE ON THE ESOPHAGUS, A REVISION WAS DONE AND THE PLATE WAS REMOVED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124367 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS W04B2753

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Other