BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 6250848 · Received January 13, 2017

    Report

    Report Number
    2520274-2017-10149
    Event Type
    Malfunction
    Date Received
    January 13, 2017
    Report Date
    December 14, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). THIS REPORT IS FOR AN UNKNOWN PRODISC-C IMPLANT/UNKNOWN LOT/QUANTITY 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 WAGNER, S.C., ET AL (2016). PERSISTENT AXIAL NECK PAIN AFTER CERVICAL DISC ARTHROPLASTY: A RADIOGRAPHIC ANALYSIS. THE SPINE JOURNAL. 16: 851-856. THE PURPOSE OF THE PRESENT STUDY IS TO PERFORM A SINGLE CENTER EVALUATION OF PATIENTS WHO UNDERWENT CERVICAL DISC ARTHROPLASTY (CDA) WHO EXPERIENCED POSTOPERATIVE AXIAL NECK PAIN, AND COMPARE PRE- AND POSTOPERATIVE RADIOGRAPHIC PARAMETERS TO DETERMINE IF THERE ARE SPECIFIC RADIOLOGICAL LANDMARKS ASSOCIATED WITH WORSE POSTOPERATIVE OUTCOMES. THE SURGICAL DATABASE AT THE AUTHORS' INSTITUTION WAS QUERIED TO IDENTIFY ALL PATIENTS WHO HAD UNDERGONE CDA BETWEEN (B)(6) 2008 AND (B)(6) 2012. THIS SEARCH YIELDED A TOTAL OF 316 PATIENTS, AND 285 (217 MALES, 68 FEMALES) PATIENTS HAD AVAILABLE RADIOGRAPHIC AND FOLLOW-UP INFORMATION. THE AVERAGE RADIOGRAPHIC FOLLOW-UP WAS 13.5 MONTHS. THE MEDTRONIC PRESTIGE CERVICAL ARTHROPLASTY SYSTEM WAS USED IN THE MAJORITY OF PATIENTS (94.7%), WHEREAS THE SYNTHES PRODISC-C SYSTEM WAS USED IN THE REMAINING PATIENTS (5.2%). THE AUTHORS FOUND THAT 49 (17.2%) PATIENTS COMPLAINED OF AXIAL NECK PAIN AT 3 MONTHS OR MORE, COMPARED WITH 236 (82.8%) WHO DID NOT REPORT NECK PAIN POSTOPERATIVELY. THE RATES OF OSTEOLYSIS IN PATIENTS WITH PERSISTENT POSTERIOR NECK PAIN WERE 11.5% VERSUS 5.8% IN THOSE WITHOUT PAIN. INTERESTINGLY, THE RATE OF HETEROTOPIC OSSIFICATION (HO) WAS 22.6% IN THE NECK PAIN GROUP AND 11.7% IN THOSE WITH NO NECK PAIN. OF THE 49 PATIENTS WITH POSTOPERATIVE NECK PAIN, SEVEN (7) PATIENTS EXPERIENCED OSTEOLYSIS, FOURTEEN (14) PATIENTS EXPERIENCED HETEROTOPIC OSSIFICATION (HO), ONE PATIENT EXPERIENCED SUBSIDENCE, AND TWO (2) PATIENTS UNDERWENT REVISION; OF THE PATIENTS WITH NO POSTOPERATIVE NECK PAIN, FIFTEEN (15) PATIENTS EXPERIENCED OSTEOLYSIS, 30 PATIENTS EXPERIENCED HO, ONE PATIENT EXPERIENCED SUBSIDENCE, AND FOUR (4) PATIENTS UNDERWENT REVISION. OF THE 49 PATIENTS WITH POSTOPERATIVE NECK PAIN, 2 PATIENTS EXPERIENCED DEVICE LOOSENING, AND TWO PATIENTS EXPERIENCED DEVICE MIGRATION. OF THE 236 PATIENTS WITH NO POSTOPERATIVE NECK PAIN, TWO PATIENTS EXPERIENCED DEVICE LOOSENING. THIS MEDWATCH REFERS TO THE TWO PATIENTS WHO EXPERIENCED DEVICE LOOSENING. THIS REPORT IS FOR UNKNOWN PRODISC-C IMPLANT. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4). A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31525 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1