BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPAND CORPECTOMY SPACER SMALL 12X14 3.5/3.5 DEGREE

    MDR report key: 2082178 · Received April 29, 2011

    Report

    Report Number
    3004142400-2011-00010
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR EVAL AS IT REMAINS IN THE PT AT THIS TIME. HOWEVER, A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MFG RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS ACCORDING TO THE DESCRIPTIONS OF THE PRODUCT USED WITH THE CONCOMMITANT DEVICE. ALL RECORDS REVEALED ALL PRODUCT LOTS WERE MFG WITHIN SPECIFICATIONS, MAINTAINED, AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. BASED ON RECORD REVIEW OF ALL AVAILABLE INFO, IT IS DETERMINED THE XPAND CORPECTOMY SPACER SMALL 12X14 3.5/3.5 DEGREE 32-40MME DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MFG PROCESS. THERE IS NO INDICATION THAT THE ISSUE WAS A RESULT OF PRODUCT DEFECT. IF GLOBUS MEDICAL, INC. IS NOTIFIED OF A CHANGE IN PT STATUS, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WITH ANY AVAILABLE, ADDITIONAL, AND/OR EVAL INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN XPAND SPACER LOST HEIGHT IN A PT POST-OPERATIVELY. FILMS SHOW ON (B)(6) 2011 THE SPACER WAS EXPANDED TO THE DESIRED HEIGHT DURING IMPLANTATION. FILMS FROM PT'S ROUTINE F/U VISIT ON (B)(6) 2011 SHOWS THE SPACER NO LONGER AT THE EXPANDED HEIGHT, HOWEVER, REMAINS IN THE ANTERIOR POSITION AT C4-5, WHERE ORIGINALLY IMPLANTED. THE PT SHOWS NO SYMPTOMS, THEREFORE, THERE ARE NO PLANS TO REMOVE THE SPACER AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPAND CORPECTOMY SPACER SMALL 12X14 3.5/3.5 DEGREE XPAND CORPECTOMY SPACER MQP GLOBUS MEDICAL, INC. 116.110

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other