BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGUAR CAGE

    MDR report key: 3863540 · Received June 10, 2014

    Report

    Report Number
    1526439-2014-11600
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 21, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MCV
    Adverse Event
    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: ¿DOES ALENDRONATE DISTURB THE HEALING PROCESS OF POSTERIOR LUMBAR INTERBODY FUSION? A PROSPECTIVE RANDOMIZED TRIAL (NAGAHAMA, K.) PUBLICATION DATE: APR 2011.¿ IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. : NOT RETURNED.

    Description of Event or Problem · 1

    POST MARKET SURVEILLANCE: JAGUAR. CAGE SUBSIDENCE. DOES ALENDRONATE DISTURB THE HEALING PROCESS OF POSTERIOR LUMBAR INTERBODY FUSION? A PROSPECTIVE RANDOMIZED TRIAL (NAGAHAMA, K.) PUBLICATION DATE: APR 2011. N=6 CAGE SUBSIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338409 JAGUAR CAGE SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM MCV DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention