BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER 2 SCREW

    MDR report key: 6568272 · Received May 15, 2017

    Report

    Report Number
    1526439-2017-10363
    Event Type
    Injury
    Date Received
    May 15, 2017
    Report Date
    April 18, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MRW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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: WANG, Q. Y., HUANG, M. G., OU, D. Q., XU, Y. C., DONG, J. W., YIN, H. D., ... & RONG, L. M. (2017). ONE-STAGE EXTREME LATERAL INTERBODY FUSION AND PERCUTANEOUS PEDICLE SCREW FIXATION IN LUMBAR SPINE TUBERCULOSIS. JOURNAL OF MUSCULOSKELETAL & NEURONAL INTERACTIONS, 17(1), 450. N= 1 POST-OP LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349161 VIPER 2 SCREW UNKNOWN VIPER SCREW MRW DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R