BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE CERVICAL DISC SYSTEM

    MDR report key: 4330721 · Received December 15, 2014

    Report

    Report Number
    1030489-2014-04733
    Event Type
    Injury
    Date Received
    December 15, 2014
    Date of Event
    November 7, 2014
    Report Date
    November 24, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MJO
    PMA / PMN Number
    P090029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: SUNG BAE PARK, M.D. ET AL. X-RAY BASED KINEMATIC ANALYSIS OF CERVICAL SPINE ACCORDING TOPROSTHESIS DESIGNS: ANALYSIS OF THE (B)(6). BSD JOURNAL OF SPINAL DISORDERS AND TECHNIQUES PUBLISH AHEAD OF PRINT DOI:10.1097/BSD.0B013E318288A923. BORAMAE MEDICAL CENTER, SEOUL, KR. (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 BY PARK ET AL IN A LITERATURE ARTICLE TITLED ¿X-RAY BASED KINEMATIC ANALYSIS OF CERVICAL SPINE ACCORDING TO PROSTHESIS DESIGNS: ANALYSIS OF THE (B)(6)¿ THAT: A RETROSPECTIVE STUDY WAS DONE TO IDENTIFY SIGNIFICANT KINEMATIC CHANGES IN THE CERVICAL SPINE AFTER CERVICAL ARTIFICIAL DISC REPLACEMENT (ADR) USING PROSTHESES WITH DIVERSE DESIGNS. THE COHORT COMPRISED 58 PATIENTS (35 MEN AND 23 WOMEN) WITH A MEAN AGE OF 45.8 YEARS WHO UNDERWENT SINGLE-LEVEL CERVICAL ADR BETWEEN APRIL 2005 AND OCTOBER 2008 FOR RADICULOPATHY. THE PATIENTS WERE DIVIDED INTO FOUR GROUPS ACCORDING TO THE DEVICE THEY RECEIVED: (B)(6). THE MEAN FOLLOW-UP DURATION WAS 41 ± 12.1 MONTHS. CERVICAL ADRS WERE PERFORMED FROM C3¿4 TO C6¿7, AND THE LEVEL OF C5¿6 WAS THE MOST COMMON SITE OF ADR. LATERAL NEUTRAL, FLEXION, AND EXTENSION RADIOGRAPHS OF THE CERVICAL SPINE WERE OBTAINED PREOPERATIVELY AND AT 12, 24, AND 36 MONTHS AFTER SURGERY. SEVERAL KINEMATIC PARAMETERS, INCLUDING LORDOTIC ANGLES AND ROMOF THE CERVICAL SPINE, INDEX LEVEL, AND SUPERIOR AND INFERIOR ADJACENT DISC LEVELS, WERE ASSESSED PREOPERATIVELY AND AT PREDEFINED FOLLOW-UP TIME POINTS. THERE WERE NINE CASES OF ASD FOR ALL GROUPS DURING THE FOLLOW-UP PERIOD: C4-5 (N = 2), C5-6 (N = 5), C6-7 (N = 1) AND C7-T1 (N = 1). ONLY TWO PATIENTS DEVELOPED ASD IN THE INFERIOR ADJACENT SEGMENT (ONE CASE IN THE (B)(6)GROUP; ONE CASE IN THE (B)(6) GROUP). THE OTHER CASES OCCURRED IN THE SUPERIOR ADJACENT SEGMENT. TWO OF 14 PATIENTS (14.2%) IN THE (B)(6) GROUP, FIVE OF 20 PATIENTS (25%) IN THE (B)(6) GROUP, AND ONE OF 11 PATIENTS (9%) IN THE (B)(6) GROUP DEVELOPED ASD DURING FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821459 PRESTIGE CERVICAL DISC SYSTEM PROSTHESIS, INTERVERTEBRAL DISC MJO WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other