BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHIR® ANTERIOR CERVICAL SYSTEM

    MDR report key: 4681396 · Received April 10, 2015

    Report

    Report Number
    1030489-2015-00773
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    March 13, 2015
    Report Date
    March 13, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 8792113 AND 510K # K994239 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING C5-C6 ANTERIOR CERVICAL DECOMPRESSION AND FUSION SURGERY, ONE OF THE SCREWS WOULD NOT TIGHTEN DOWN IN THE PLATE AND "JUST SPUN AROUND." THE SURGEON HAD TO REPLACE THE SCREW AND INDICATED THAT THE SCREW WAS POSSIBLY "BLUNT OR CRACKED." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239218 ZEPHIR® ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H5149164

    Patients

    Seq Age Sex Outcome Treatment
    1 CERVICAL PLATE SYSTEM