BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY SYNTHES SPINE ROD

    MDR report key: 3904208 · Received July 1, 2014

    Report

    Report Number
    1526439-2014-11650
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 6, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    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 RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    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

    PLAINTIFF¿S ATTORNEY REPORTS THAT ON OR ABOUT (B)(6) 2008, WHERE SEVERAL DEPUY SPINE AND/OR DEPUY SYNTHES SALES PRODUCTS WERE INSTALLED INCLUDING RODS, SCREWS AND A CAGE. ON OR AROUND (B)(6) 2012, THE PATIENT HEARD AN AUDIBLE POP IN HIS LOWER BACK. ON OR ABOUT (B)(6) 2012, THE PATIENT PRESENTED TO THE HOSPITAL FOR PAIN IN HIS BACK FOLLOWING THE AUDIBLE POP IN HIS LOWER BACK. A CT SCAN WAS PERFORMED AND IT WAS DETERMINED THAT THE METAL RODS IN THE PATIENT HAD FRACTURED. HOWEVER, NO SURGICAL INTERVENTION WAS NEEDED AT THAT TIME. ON OR ABOUT (B)(6) 2012, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THE FAILED RODS AND CONCOMITANT DEVICE SCREWS. THE FOLLOWING MFG. MEDWATCH REPORT NUMBERS ARE BEING FILED FOR THE TWO RODS THAT ARE REPORTED TO HAVE BROKEN POST-OPERATIVELY: 1526439-2014-11649, 1526439-2014-11650.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383045 DEPUY SYNTHES SPINE ROD APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS, CAT# & QTYS UNKNOWN| CAGE, CAT# UNKNOWN