BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER X-CHANGE BONE PLUG 10MM

    MDR report key: 1629239 · Received February 5, 2010

    Report

    Report Number
    9610726-2009-00269
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    September 4, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JDI
    PMA / PMN Number
    K980843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION # (B) (4). THERE ARE 2 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DEVICE BROKE OR DISASSEMBLED DURING USE) AND PRODUCT CODE JDI.

    Description of Event or Problem · 1

    DEVICE BROKE OR DISASSEMBLED DURING USE. DURING SURGERY, THE BONE PLUG STUCK IN THE CANAL ON THE WAY, SO THE SURGEON TAPPED IT TWO TIMES LIGHTLY BY A HAMMER THEN, IT DID NOT FEEL THAT THE BONE PLUG STUCK ANY MORE HOWEVER, A PIECE OF BROKEN BONE PLUG CAME OUT FROM THE CANAL UPON IRRIGATING THE CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER X-CHANGE BONE PLUG 10MM IMPLANT JDI STRYKER ORTHOPAEDICS LIMERICK NA L2676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other