BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 4727685 · Received April 24, 2015

    Report

    Report Number
    2530088-2015-10125
    Event Type
    Injury
    Date Received
    April 24, 2015
    Report Date
    April 21, 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. TRACEY, R. ET AL (2014). OUTCOMES OF SINGLE-LEVEL CERVICAL DISC ARTHROPLASTY VERSUS ANTERIOR CERVICAL DISCECTOMY AND FUSION. JOURNAL OF CLINICAL NEUROSCIENCE, 21, 1905¿1908. THIS REPORT IS FOR AN UNKNOWN PRODISC-C SYSTEM/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 THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, TRACEY, R. ET AL (2014). OUTCOMES OF SINGLE-LEVEL CERVICAL DISC ARTHROPLASTY VERSUS ANTERIOR CERVICAL DISCECTOMY AND FUSION. JOURNAL OF CLINICAL NEUROSCIENCE, 21, 1905¿1908. THE AUTHORS RETROSPECTIVELY REVIEWED ALL PATIENTS FROM A SINGLE MILITARY TERTIARY MEDICAL CENTER BETWEEN AUGUST 2008 TO AUGUST 2012 WHO UNDERWENT SINGLE-LEVEL CERVICAL DISC ARTHROPLASTY (CDA) OR SINGLE-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AND COMPARED THEIR CLINICAL OUTCOMES AND COMPLICATIONS. IN THE CDA GROUP, THE DEVICE OF COMPETITOR WAS USED IN 94.7 PERCENT OF PATIENTS AND THE SYNTHES DEVICE, PRODISC-C SYSTEM, IN THE REMAINDER OF THE PATIENTS. A TOTAL OF 259 CONSECUTIVE PATIENTS WERE INCLUDED IN THE STUDY, 171 PATIENTS (134 MALES AND 37 FEMALES WITH MEAN AGE 40.5 YEARS) IN THE CDA GROUP WITH AN AVERAGE FOLLOW-UP OF 9.8 MONTHS AND 88 PATIENTS (65 MALES AND 23 FEMALES WITH MEAN AGE 47.5 YEARS) IN THE ACDF GROUP WITH AN AVERAGE FOLLOW-UP OF 11.8 MONTHS. DATA COLLECTION INCLUDED PATIENT DEMOGRAPHIC INFORMATION, OUTCOMES AND COMPLICATIONS. RESULTS OF THE CDA GROUP INCLUDED THE FOLLOWING: SEVENTEEN PATIENTS HAD INCOMPLETE RELIEF OF PRE-OPERATIVE SYMPTOMS. THESE PATIENTS HAD PERSISTENT POSTERIOR NECK PAIN, CONTINUED RADICULOPATHY, CONTINUED MYELOPATHY, OR A COMBINATION OF THE AFOREMENTIONED SYMPTOMS. PERSISTENT POSTERIOR NECK PAIN WAS OBSERVED POST-OPERATIVELY IN 27 PATIENTS. THIS GROUP EXPERIENCED RECURRENT LARYNGEAL NERVE INJURY (2.9 PERCENT), PERSISTENT DYSPHAGIA (5.8 PERCENT) AND NERVE ROOT INJURY (0.6 PERCENT). THE REOPERATION RATE WAS 3.5 PERCENT, INCLUDING POSTERIOR DECOMPRESSION AND FUSION, ADJACENT SEGMENT DEGENERATION REQUIRING SURGERY, AND CONVERSION OF CDA TO ACDF. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PRODISC-C SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271925 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention