BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERPLATE CERVICAL IFD

    MDR report key: 2624046 · Received February 2, 2009

    Report

    Report Number
    3003597504-2009-00001
    Event Type
    Injury
    Date Received
    February 2, 2009
    Date of Event
    January 7, 2009
    Report Date
    January 30, 2009
    Manufacturer
    RSB SPINE
    Product Code
    OVD
    PMA / PMN Number
    K071922
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A TWO LEVEL ACDF WAS PERFORMED AT C 5-6 AND C 6-7 IN (B)(6) 2008. THE INTERPLATE AT C 6-7 WAS INVERTED TO SIMPLIFY INSERTION OF THE TWO ROUND HOLE SCREWS. THIS RESULTED IN THE TWO INTERPLATE SLOT TABS DIRECTLY OPPOSING EACH OTHER WITH A NARROW GAP IN BETWEEN. EACH TAB SLID AS INTENDED UNTIL THE TABS IMPINGED, AT WHICH POINT THE CAUDAL TAB RODE UP OVER THE CEPHALAD TAB. THE PT WAS REVISED TO TWO INVERTED INTERPLATES IN (B)(6) 2009. PT WAS DISCHARGED THE NEXT DAY AND AT LAST REPORT RECOVERY IS PROCEEDING ROUTINELY. WHILE THERE WAS NO DEVIC MALFUNCTION THE INCIDENT IS BEING REPORTED BECAUSE SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERPLATE CERVICAL IFD INTERVERTEBRAL FUSION DEVICE WITH BONE OVD RSB SPINE EK001

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R