BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX SPINE SYSTEM

    MDR report key: 3428754 · Received October 18, 2013

    Report

    Report Number
    3004717358-2013-00001
    Event Type
    Injury
    Date Received
    October 18, 2013
    Date of Event
    September 11, 2013
    Report Date
    October 17, 2013
    Manufacturer
    SPINECRAFT
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION AND PERFORMANCE EVALUATION OF THE TOQUE-LIMITING HANDLES USED DURING THE PROCEDURE FOUND NO ABNORMALITIES THAT COULD BE ATTRIBUTED TO THE INCIDENT REPORTED BY THE CUSTOMER. A REVIEW OF THE DHRS OF THE TORQUE-LIMITING HANDLE AND CONCOMITANT DEVICES IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THE TORQUE-LIMITING HANDLES AND CONCOMITANT DEVICES THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A REVIEW OF THE COMPLAINT TREND ANALYSIS IDENTIFIED NO OBSERVED TRENDS FOR ISSUES OF THIS NATURE. AT THIS TIME, NO CONCLUSION CAN BE DRAWN AND THE COMPLAINT IS CONSIDERED TO BE CLOSED. RELEVANT HISTORY: PT WAS NON-COMPLIANT WITH BRACING AFTER INITIAL SURGERY AND THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT.

    Description of Event or Problem · 1

    PT HAD APEX IMPLANTED ON (B)(6) 2013 AND WAS REVISED ON (B)(6) 2013. AT THE INDEX SURGERY, THE PT HAD 18 APEX SCREWS IMPLANTED FROM T10 TO THE ILIUM ALONG WITH TWO 6.0X450 TITANIUM RODS AND TWO CROSS CONNECTORS. AT TIME OF EVENT, IT WAS NOTED THAT THE RODS HAD PULLED OUT OF THE ILIAC BOLTS. SCREWS AND SET SCREWS WERE INTACT. PT WAS REVISED WITH LONGER RODS AND A ROD TO ROD CONNECTOR WAS IMPLANTED ON THE DISTAL TIP OF THE ROD TO CREATE A "JAM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535895 APEX SPINE SYSTEM TORQUE-LIMITING HANDLE NKB SPINECRAFT BM552425

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R ON AUGUST 21, 2013: CONCOMITANT PRODUCTS:| 1 EACH OF LX6-3139| 14 EACH OF PF6-7050| 4 EACH OF SS6-MPH95-T30L| 2 EACH OF PF6-7750| 2 EACH OF PF6-8580| 2 EACH OF 6000-450| 14 EACH OF SS6-MPH95-T30| 1 EACH OF PP3011| 1 EACH OF LX6-4871