BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPAL SPACER 10MM X 28MM

    MDR report key: 2023818 · Received March 14, 2011

    Report

    Report Number
    2530088-2011-00058
    Event Type
    Injury
    Date Received
    March 14, 2011
    Report Date
    February 24, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MQP
    PMA / PMN Number
    K011037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING THE INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    PATIENT RETURNED TO SURGEON FOR POST OP VISIT POST OPAL SPACER AND CONSTRUCT IMPLANTATION COMPLETED ON (B)(6) 2010. AN X-RAY SHOWED THE OPAL IMPLANT HAD MIGRATED OUT TOWARDS THE SPINAL CANAL. SURGEON REMOVED THE OPAL IMPLANT ONLY AND INSTALLED A TRANSCONNECTOR ON THE CONSTRUCT TO STABILIZE THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPAL SPACER 10MM X 28MM OPAL SPACERS MQP SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention