BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY SYNTHES SPINE SCREWS

    MDR report key: 3892063 · Received June 24, 2014

    Report

    Report Number
    1526439-2014-11628
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION 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. NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS REVISION OF SPINAL CONSTRUCT WAS PERFORMED BECAUSE OF SUBOPTIMAL POSITIONED DEPUY SYNTHES SPINE SCREWS. NO PRODUCT IS BEING RETURNED FOR EVALUATION AND THE AFFILIATE IS UNABLE TO PROVIDE PRODUCT INFORMATION OR THE QUANTITY OF SCREWS THAT WERE INVOLVED IN THIS EVENT. AS SUCH, THIS MEDWATCH REPORT IS BEING SUBMITTED TO DOCUMENT THE EVENT INVOLVING AN UNKNOWN QUANTITY OF UNIDENTIFIED DEPUY SYNTHES SPINE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369043 DEPUY SYNTHES SPINE SCREWS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention