BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTERPIECE SPINAL SYSTEM

    MDR report key: 6184689 · Received December 19, 2016

    Report

    Report Number
    1030489-2016-03441
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Report Date
    November 25, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: TAKASHI ADACHI, TAKETOSHI KUSHIDA, ATSUSHI IKEURA, HIROKAZU IIDA."TREATMENT EXPERIENCE AND SHORT TERM OUTCOMES OF UNILATERAL OPEN-DOOR CERVICAL LAMINECTOMY WITH PLATE FIXATION SYSTEM". MEAN AGE OF PATIENTS WAS 69.6 YEARS. 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 IN THE ABSTRACT THAT 24 PATIENTS WHO UNDERWENT CERVICAL LAMINOPLASTY WITH PLATE FIXATION SYSTEM FROM (B)(6) 2014 TO (B)(6) 2015. POST-OPERATIVELY, ONE SCREW BACK OUT FROM C3 LATERAL MASS WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837720 CENTERPIECE SPINAL SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR