BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SABER I/F CAGE

    MDR report key: 3853832 · Received June 6, 2014

    Report

    Report Number
    1526439-2014-11576
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    May 21, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MCV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FOLLOW UP REPORT IS ANTICIPATED AS THE PRODUCT HAS NOT BEEN RETURNED. THE SOURCE OF THE REPORT IS THE FOLLOWING LITERATURE SOURCE: ¿COMPARISON OF UNILATERAL VERSUS BILATERAL INSTRUMENTED TRANSFORAMINAL LUMBAR INTERBODY FUSION IN DEGENERATIVE LUMBAR DISEASES (XUE, H.) PUBLICATION DATE JAN 2012.¿ IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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

    POST MARKET SURVEILLANCE REVIEW OF LITERATURE FOUND REPORT OF CEREBRAL SPINAL FLUID (CSF) LEAKAGE INVOLVING A SABER I/F CAGE. ARTICLE TITLE: ¿COMPARISON OF UNILATERAL VERSUS BILATERAL INSTRUMENTED TRANSFORAMINAL LUMBAR INTERBODY FUSION IN DEGENERATIVE LUMBAR DISEASES (XUE, H.) PUBLICATION DATE JAN 2012.¿ CLINICAL FINDINGS DETERMINED BY MEDICAL SAFETY AND COMPLAINT MANAGEMENT: N=4, CSF LEAK.

    Description of Event or Problem · 1

    POST MARKET SURVEILLANCE REVIEW OF LITERATURE FOUND REPORT OF CEREBRAL SPINAL FLUID (CSF) LEAKAGE INVOLVING A SABER I/F CAGE. ARTICLE TITLE: "COMPARISON OF UNILATERAL VERSUS BILATERAL INSTRUMENTED TRANSFORAMINAL LUMBAR INTERBODY FUSION IN DEGENERATIVE LUMBAR DISEASES (XUE, H.) PUBLICATION DATE JAN 2012". CLINICAL FINDINGS DETERMINED BY MEDICAL SAFETY AND COMPLAINT MANAGEMENT: N=4, CSF LEAK. THE FOLLOWING MFG MEDWATCH REPORTS ARE BEING FILED FOR THE FOUR PATIENTS/EVENTS. 1526439-2014-11576, 1526439-2014-11581, 1526439-2014-11582, 1526439-2014-11583.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332074 SABER I/F CAGE SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM MCV DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention