BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 2720903 · Received August 30, 2012

    Report

    Report Number
    1030489-2012-01535
    Event Type
    Injury
    Date Received
    August 30, 2012
    Date of Event
    March 14, 2012
    Report Date
    August 1, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART NUMBER G8792113, LOT # H11K5400, PART NUMBER G8792113, LOT # H11L2467. ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8792113, 510K # K994329 WAS CLEARED IN THE UNITED STATES. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL PROCEDURE AT C3-C5. IT WAS REPORTED THAT ONE OF THE SCREWS BACKED OUT AND IS MISSING. IT IS ASSUMED THAT THE BACKED OUT SCREW PERFORATED THE ESOPHAGUS AND COULD NOT BE FOUND IN THE BODY. DYSPHAGIA WAS CONFIRMED POST OPERATIVELY. A REVISION SURGERY IS PLANNED ONCE THE PATIENT'S ESOPHAGUS HAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1