BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 3771202 · Received April 24, 2014

    Report

    Report Number
    2530088-2014-10064
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 11, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MEAN AGE 42.1 YEARS FOR PRODISC-C GROUP (103 PATIENTS). TOTAL 103 PATIENTS IN PRODISC-C GROUP: 46 MALES AND 57 FEMALES. ARTICLE PUBLISHED: 2012. EXACT DATE THE ARTICLE WAS PUBLISHED IS UNKNOWN. THIS REPORT IS FOR 1 UNKNOWN PRODISC-C, UNKNOWN PART/UNKNOWN LOT. DARDEN. B (2012), PRODISC-C CERVICAL DISK ARTHROPLASTY. SEMINARS IN SPINE SURGERY, ELSEVIER, VOL 24, 8-13. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE; "PRODISC C CERVICAL DISK ARTHROPLASTY.- BRUCE V. DARDEN". THE FOOD AND DRUG ADMINISTRATION INVESTIGATIONAL DEVICE EXEMPTION TRIAL FOR PRODISC-C CERVICAL DISK ARTHROPLASTY WAS CONDUCTED. A TOTAL OF 209 PATIENTS WERE ENROLLED, 106 IN THE ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) ARM AND 103 IN THE PRODISC-C ARM. THE ACDF GROUP HAD A MEAN AGE OF 43.5 YEARS (49 MALES AND 57 FEMALES) AND THE PRODISC-C GROUP HAD A MEAN AGE OF 42.1 YEARS (46 MALES AND 57 FEMALES). C5-6 WAS THE MOST COMMON LEVEL TREATED IN BOTH GROUPS (57.5% ACDF, 56.3% PRODISC-C). THE INTRAOPERATIVE TIME AND BLOOD LOSS WERE BOTH STATISTICALLY SIGNIFICANTLY MORE IN THE PRODISC-C GROUP (107.2 MINUTES VS 93.7 MINUTES, 83.5 CC VS 63.5 CC), BUT WAS NOT CLINICALLY SIGNIFICANT. BY ALL SELF-REPORTED CLINICAL PARAMETERS, BOTH GROUPS IMPROVED SIGNIFICANTLY FROM BASELINE BUT THERE WAS NO STATISTICAL SIGNIFICANCE IN THE IMPROVEMENT IN EITHER GROUP AT 24 MONTHS. THE STUDY THEN REPORTED OVERALL SUCCESS BASED ON NDI IMPROVEMENT >/= 20% FROM BASELINE, NEUROLOGICAL SUCCESS, DEVICE SUCCESS (NO FURTHER SURGERIES AT THE INDEX LEVEL) AND ABSENCE OF IMPLANT RELATED ADVERSE EVENTS. THE OVERALL SUCCESS WAS 72% IN THE PRODISC-C GROUP AND 68.3% IN THE ACDF GROUP, SHOWING NON-INFERIORITY OF THE PRODISC-C CERVICAL DISK ARTHROPLASTY. AN ADDITIONAL ANALYSIS USING 6 HEALTH-RELATED QUALITY OF LIFE END-POINTS WAS CARRIED OUT BY EVALUATING THE MINIMUM CLINICALLY IMPORTANT DIFFERENCES IN THE MEASURES (NDI SUCCESS, ABSENCE OF DEVICE FAILURE, WILLINGNESS TO UNDERGO SURGERY AGAIN, ABSENCE OF FUSION OF PRODISC-C, ABSENCE OF PSEUDOARTHROSIS OF ACDF PATIENTS, IMPROVED OF NECK/ARM PAIN ON THE VISUAL ANALOG SCALE (VAS), AND ABSENCE OF STRONG NARCOTIC OR MUSCLE RELAXANT USE) THIS POST HOC EVALUATION SHOWED SUPERIORITY OF PRODISC-C (72.7% VS 60.4%) COMPARED WITH ACDF. THE FOUR YEAR INTERIM RESULTS OF THE PRODISC-C IDE STUDY, WHICH INCLUDED PATIENTS UNDERGOING PRODISC-C CERVICAL DISK ARTHROPLASTY AFTER THE STUDY CLOSED AS CONTINUED ACCESS (CA) CASES. THESE RESULTS INCLUDED THE 209 PATIENTS FROM THE PRO-DISC IDE STUDY AND THE 136 PATIENTS OF THE CA GROUP. AT 48 MONTHS, 3 PRODISC-C PATIENTS REQUIRED ADDITIONAL SURGERY FOR CONTINUED AXIAL PAIN AND ALL THE 3 PATIENTS WERE REVISED TO FUSION. 3 PATIENTS WITHIN THE CA HAD REVISION SURGERY AT THE INDEX LEVEL, 1 TO REPOSITION THE IMPLANTS AND 2 WERE CONVERTED TO ACDF FOR ONGOING AXIAL PAIN. THIS IS REPORT 1 OF 4 FOR (B)(4). THIS REPORT FOR 1 UNKNOWN PRODISC-C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250072 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention