BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DISCOVER ARTIFICIAL DISC

    MDR report key: 6570610 · Received May 16, 2017

    Report

    Report Number
    1526439-2017-10364
    Event Type
    Injury
    Date Received
    May 16, 2017
    Report Date
    April 18, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    ODP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRODUCT CODE UNKNOWN. THIS COMPLAINT WAS GENERATED FROM LITERATURE REVIEW FOR HEALTH AUTHORITY REPORTING PURPOSES. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE PMS IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. 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: QI, M., CHEN, H., CAO, P., TIAN, Y., & YUAN, W. (2013). INCIDENCE AND RISK FACTORS ANALYSIS OF HETEROTOPIC OSSIFICATION AFTER CERVICAL DISC REPLACEMENT. CHINESE MEDICAL JOURNAL, 127(22), 3871-3875. (B)(4). NO. OF HO PATIENTS IN SINGLE LEVEL GROUP (GRADE III=4 ) (GRADE IV=2). NO. OF HO PATIENTS IN DOUBLE LEVEL GROUP (GRADE III =3) (GRADE IV=1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351816 UNKNOWN DISCOVER ARTIFICIAL DISC UNKNOWN ODP DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other