BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER2 X-TAB POLY SCREW

    MDR report key: 6132057 · Received November 29, 2016

    Report

    Report Number
    1526439-2016-10881
    Event Type
    Injury
    Date Received
    November 29, 2016
    Report Date
    November 3, 2016
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: PRODUCT INFORMATION NOT AVAILABLE. COMPLAINT IS A REPORTABLE ADVERSE EVENT BASED ON SURGICAL WOUND REVISION REQUIRING REOPERATION REPORTED IN LITERATURE ARTICLE. FOUR (4) CASES SURGICAL WOUND REVISION REPORTED IN LITERATURE ARTICLE. NO PRODUCT FAILURE INDICTED. DEPUY SPINE REPORTS ALL NON-PLANNED REVISIONS AS MDR EVENTS, REGARDLESS OF MANUFACTURER OF DEVICES BEING REMOVED. . NO PATIENT SPECIFIC IDENTIFIERS PROVIDED. THREE REQUESTS FOR ADDITIONAL INFORMATION SENT TO AUTHOR AND NO RESPONSE RETURNED. ONE MEDWATCH WILL BE SENT FOR FOUR CASES. 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. SAMPLE NOT AVAILABLE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: KERIC ET AL: EVALUATION OF SURGICAL STRATEGY OF CONVENTIONAL VS. PERCUTANEOUS ROBOT-ASSISTED SPINAL TRANS-PEDICULAR INSTRUMENTATION IN SPONDYLODISCITIS RECEIVED: 6 FEBRUARY 2016 / ACCEPTED: 26 APRIL 2016. N=2 REVISION MISPLACED SCREW. N=4 REVISION LOOSENED SCREW. N=7 WOUND INFECTION. N=4 SURGICAL WOUND REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782577 VIPER2 X-TAB POLY SCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R