BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 6247868 · Received January 12, 2017

    Report

    Report Number
    2530088-2017-10006
    Event Type
    Injury
    Date Received
    January 12, 2017
    Date of Event
    November 4, 2015
    Report Date
    December 14, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THIS REPORT IS FOR UNKNOWN PRODISC-C/UNKNOWN QUANTITY/UNKNOWN LOT. UNKNOWN PART NUMBER, UDI UNAVAILABLE. IMPLANT/EXPLANT DATE: UNKNOWN. 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: JANSSEN, M., ET AL. (2015). PRODISC-C TOTAL DISC REPLACEMENT VERSUS ANTERIOR CERVICAL DISCECTOMY AND FUSION FOR SINGLE-LEVEL SYMPTOMATIC CERVICAL DISC DISEASE. THE JOURNAL OF BONE AND JOINT SURGERY, VOL 97:1738-47. USA. THE PURPOSE OF THE STUDY WAS TO REPORT THE SEVEN-YEAR EFFICACY AND SAFETY OUTCOMES OF A RANDOMIZED CONTROLLED TRIAL IN WHICH TOTAL DISC ARTHROPLASTY WITH PRODISC-C (PDC) WAS COMPARED WITH ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) FOR THE TREATMENT OF SINGLE-LEVEL CERVICAL DEGENERATIVE DISC DISEASE. IT IS UNKNOWN WHO MANUFACTURED THE ACDF DEVICES AND WHAT DEVICES WERE USED. HOWEVER, ARTICLE STATED THAT PLATE(S) WAS USED. TWO HUNDRED AND NINE PATIENTS AT 13 SITES WERE RANDOMLY TREATED WITH PDC (N=103, 55 FEMALES, MEAN AGE OF 42.1) OR WITH ACDF (N=106, 54 FEMALES, MEAN AGE OF 43.5). PATIENTS WERE ASSESSED PREOPERATIVELY; AT 5 WEEKS AND 3, 6, 12, 18, AND 24 MONTHS POSTOPERATIVE; AND THEN ANNUALLY UNTIL 7 YEARS POSTOPERATIVELY. RADIOGRAPHIC DATA WERE OBTAINED AND ANALYZED BY RADIOLOGISTS AT EACH VISIT. THE FOLLOWING COMPLICATIONS WERE REPORTED: TWO (2) PATIENTS HAD SURGERY FOR DEVICE-RELATED EVENTS: INDEX LEVEL. DEVICE ISSUE WAS NOT PROVIDED. ONE (1) PATIENT HAD SURGERY FOR DEVICE-RELATED EVENTS: OTHER. DEVICE ISSUE WAS NOT PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PRODISC-C (PDC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29469 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention