BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUSTAIN R SPACER, OBLIQUE, 10X26, 9MM

    MDR report key: 1051324 · Received May 22, 2008

    Report

    Report Number
    3004142400-2008-00003
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 23, 2008
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MQP
    PMA / PMN Number
    K040284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE REPORT. A REVIEW WAS CONDUCTED ON ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS. ALL RECORDS REVEALED THE PRODUCT WAS MANUFACTURED WITHIN SPECIFICATIONS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. THE SPACER WAS RETURNED FOR TEST AND EVALUATION. THE FIRST OBSERVATION IS THAT THE SPACER APPEARS TO HAVE BEEN DAMAGED DURING SURGERY. PRODUCT DEVELOPMENT ENGINEERING CONFIRMED THE COMPLAINT AND LISTED IT AS INDETERMINATE. THEY FURTHER LISTED, "BROKE DUE TO IMPROPER IMPACTION, NO CHANGE REQUIRED."

    Description of Event or Problem · 1

    GLOBUS MEDICAL RECEIVED NOTIFICATION FROM THE HOSPITAL VIA A TELEPHONE CALL STATING THAT A GLOBUS MANUFACTURED SPACER SHATTERED DURING SURGERY. IT WAS REPORTED TO GLOBUS THAT, "SUSTAIN SPACER SHATTERED DURING SURGICAL PROCEDURE WITH DR. DEOL. THE PART BROKE INTO FOUR PIECES." BROKEN SPACER WAS RETURNED TO GLOBUS MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUSTAIN R SPACER, OBLIQUE, 10X26, 9MM SPACER MQP GLOBUS MEDICAL, INC. 304.009 GMH187BE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention