BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPAL SPACER 10MM X 24MM 13MM HEIGHT-REVOLVER

    MDR report key: 2893535 · Received December 28, 2012

    Report

    Report Number
    2520274-2012-04337
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    MAX
    PMA / PMN Number
    K072791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT FOR DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MFG RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    DURING A POSTERIOR INTERBODY LUMBAR FUSION PROCEDURE AT L5-S1, AS THE SURGEON WAS PLACING THE SECOND OPAL SPACER IN AND TAPPING THE SPACER FORWARD THE SPACER WENT THROUGH THE DISC SPACE. THE OPAL SPACER WAS DOWN TOO FAR IN THE DISC SPACE AND THE SURGEON TRIED TO RETRIEVE THE SPACER. THE PROCEDURE WAS PROLONGED FOR ABOUT 30-45 MINUTES DUE TO THIS INCIDENT. THE SURGEON WAS UNABLE TO RETRIEVE THE SECOND SPACER AND IT STILL REMAINS IN THE PT. THE SURGEON PLACED A THIRD OPAL SPACER IN THE SAME PLACE WHERE THE SECOND SPACER SHOULD HAVE BEEN TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPAL SPACER 10MM X 24MM 13MM HEIGHT-REVOLVER OPAL SPACER 10MM X 24MM 13MM HEIGHT-REVOLVER MAX SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention