BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY SYNTHES SPINE SCREW

    MDR report key: 3790723 · Received May 5, 2014

    Report

    Report Number
    1526439-2014-11487
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 3, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PUNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. DEVICE DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    PER INTERNATIONAL AFFILIATE: PROCEDURE: REVISION OF PREVIOUS FUSIONS - T8 TO S2 (5TH REVISION). FUSION AT L4/L5. PSEUDOARTHROSIS AT L5/S1. LOOSENING OF TWO SCREWS AT S2. THE SALES REPRESENTATIVE WAS AWARE OF THE EVENT ON (B)(6) 2014 BUT WAS LATE IN REPORTING THE EVENT TO THE INTERNATIONAL AFFILIATE. THE SALES REP HAS BEEN ADVISED OF THE NEED TO IMMEDIATELY REPORT ADVERSE EVENTS. THE FOLLOWING MFG MEDWATCH REPORTS WERE FILED FOR THE TWO SCREWS THAT HAD LOOSENED POST-OPERATIVELY: MFG MEDWATCH REPORT NUMBER 1526439-2014-11487; MFG MEDWATCH REPORT NUMBER 1526439-2014-11488.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267479 DEPUY SYNTHES SPINE SCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention PEDICLE SCREWS X 2| CAGE X 1