BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 4747280 · Received May 5, 2015

    Report

    Report Number
    2530088-2015-10132
    Event Type
    Injury
    Date Received
    May 5, 2015
    Date of Event
    September 10, 2013
    Report Date
    April 20, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LEHMAN RONALD AND ET AL (2013): OUTCOMES OF SINGLE-LEVEL CERVICAL DISC ARTHROPLASTY VERSUS ANTERIOR DISCECTOMY AND FUSION: A SINGLE CENTER, RETROSPECTIVE REVIEW. THE SPINE JOURNAL, VOLUME 13, ISSUE 9, PAGE 5S. THIS REPORT IS FOR UNKNOWN PRODIISC-C/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 ABSTRACT: LEHMAN RONALD AND ET AL (2013): OUTCOMES OF SINGLE-LEVEL CERVICAL DISC ARTHROPLASTY VERSUS ANTERIOR DISCECTOMY AND FUSION: A SINGLE CENTER, RETROSPECTIVE REVIEW. THE SPINE JOURNAL, VOLUME 13, ISSUE 9, PAGE 5S. A TOTAL OF ONE HUNDRED AND NINETY EIGHT PATIENTS UNDERWENT SURGERIES FOR EITHER SINGLE-LEVEL CERVICAL DISC ARTHROPLASTY (CDA) OR SINGLE-LEVEL ANTERIOR DISCECTOMY AND FUSION (ACDF) FOR THE TREATMENT OF CERVICAL RADICULOPATHY AND MYELOPATHY FROM AUGUST 2008 TO AUGUST 2012. THE CDA GROUP CONTAINED 110 PATIENTS AND THE ACDF GROUP HAD 88 PATIENTS. AVERAGE FOLLOW-UP TIME WAS 9.7 (±8.8) MONTHS. DURING THE STUDY, THE CDA AND ACDF GROUPS DEMONSTRATED 90.9% AND 86.4% RATES OF SYMPTOM RELIEF, RESPECTIVELY. 93.6% OF PATIENTS WHO UNDERWENT CDA WERE ABLE TO RETURN TO FULL ACTIVITY, COMPARED TO 88.6% IN THE ACDF GROUP. THE RATES FOR RECURRENT LARYNGEAL NERVE (RLN) INJURY AND DYSPHAGIA WERE 3.6% AND 5.5%, RESPECTIVELY, IN THE CDA GROUP. THE ACDF GROUP HAD NO RLN INJURIES AND 3.4% OF PATIENTS REPORTED DYSPHAGIA. THE CDA GROUP HAD A 16.4% RATE OF PERSISTENT POSTERIOR NECK PAIN. THE ACDF GROUP HAD 11 PATIENTS (12.5%) WITH PERSISTENT POSTERIOR NECK PAIN, AND A RATE OF SYMPTOMATIC PSEUDOARTHROSIS REQUIRING REOPERATION OF 2.3%. THE DATA SUGGEST THAT BOTH CDA AND ACDF RESULT IN APPROXIMATELY 90% (93.6% CDA AND 88.6% ACDF) OF PATIENTS WITH COMPLETE SYMPTOM RELIEF AND A RELATIVELY LOW COMPLICATION RATE. PATIENTS WHO UNDERWENT CDA HAD A HIGHER RATE OF PERSISTENT POSTERIOR NECK PAIN, AND PATIENTS WHO UNDERWENT ACDF WERE AT RISK FOR SYMPTOMATIC PSEUDOARTHROSIS. THIS IS REPORT 1 OF 1 FOR (B)(4) THIS REPORT IS FOR UNKNOWN PRODISC-C A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292778 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention