BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 4244048 · Received November 11, 2014

    Report

    Report Number
    1030489-2014-04332
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    February 8, 2013
    Report Date
    October 14, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P090029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT THIRTY-ONE PATIENTS WITH SINGLE-LEVEL CERVICAL DISC DISEASE RECEIVED THE PRESTIGE LP DISC REPLACEMENT FROM JUNE 2008 TO DECEMBER 2009. PATIENTS WERE ASSESSED AT 24 MONTHS FOLLOW-UP. STUDY INCLUDED 18 MALES, 13 FEMALES. AVERAGE AGE AT OPERATION WAS 42 YEARS (RANGE 29-54). CERVICAL ARTHROPLASTY INCLUDED C3-C4 IN 1 CASE, C4-5 IN 2 CASES AND C5-C6 IN 28 CASES. STUDENT¿S TWO-SIDED T TEST WAS USED TO ASSESS THE JOA, NDI AND VAS OF EACH PATIENT PRE-OPERATIVELY AND POST-OPERATIVELY AT 24 MONTHS. CLINICAL VALUES ARE PROVIDED IN TABLE 1. ALL PATIENTS SHOWED STATISTICALLY SIGNIFICANT IMPROVEMENT IN ALL MEASUREMENTS ABOVE AT 24 MONTHS. THE NECK PAIN DISAPPEARED COMPLETELY IN 9 PATIENTS, AND THE ARM PAIN ENTIRELY SUBSIDED IN 17 PATIENTS. THERE WAS NO CASE OF LOOSENING, MIGRATION OR SUBSIDENCE OF THE PROSTHESIS, AND NO PATIENT WAS RE-OPERATED AT AN ADJACENT LEVEL. ALL THE 19 PATIENTS WITH LORDOTIC ALIGNMENT PRE-OPERATIVE MAINTAINED THE LORDOTIC CURVATURE, EXCEPT ONE PATIENT BECAME KYPHOTIC POST-OPERATIVELY. IN SEVEN PATIENTS WITH PRE-OPERATIVE STRAIGHT ALIGNMENT, THE SPINAL ALIGNMENT IN TWO PATIENTS REMAINED STRAIGHT, FOUR PATIENTS BECAME LORDOTIC AND ONE PATIENT BECAME KYPHOTIC. IN FIVE PATIENTS WITH PRE-OPERATIVE KYPHOTIC ALIGNMENT THE SPINAL ALIGNMENT IN TWO PATIENTS BECAME LORDOTIC AND THREE PATIENTS REMAINED KYPHOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726370 PRESTIGE CERVICAL DISC SYSTEM MJO WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Other