BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RISE SPACER 8 X 26MM, 7-14MM

    MDR report key: 3983289 · Received July 3, 2014

    Report

    Report Number
    3004142400-2014-00031
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    OVD
    Adverse Event
    Yes
    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 RETURNED FOR EVAL, 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 CONCOMITANT DEVICE. ALL RECORDS REVEALED ALL PRODUCT LOTS WERE MANUFACTURED WITHIN SPECS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AN OPERATING PROCEDURES. THE RETURNED IMPLANT WAS VISUALLY INSPECTED, AND WAS STILL INTACT, DIMENSIONALLY ACCURATE AND FUNCTIONAL. THE IMPLANT WAS DISASSEMBLED TO EVALUATE THE INTERNAL COMPONENTS, AND ALL COMPONENTS WERE INTACT. THE DRIVE SCREW AND BACK RAMP COMPONENTS MEASURED WITHIN TOLERANCE. ALL FILMS AVAILABLE DO NOT SHOW ANY UNUSUAL REPRESENTATION OF THE IMPLANT. THE EXACT CAUSE OF THE REPORTED LOSS OF HEIGHT CANNOT BE ASCERTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED PT UNDERWENT REVISION SURGERY DUE TO REPORTED COLLAPSE OF A RISE IMPLANT. THE REVISION SURGERY TOOK PLACE (B)(6) 2014. INITIAL SURGERY WAS (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391999 RISE SPACER 8 X 26MM, 7-14MM RISE SPACER OVD GLOBUS MEDICAL, INC. 193.002 WTM336EB

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention