BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZUMA-C LOCKING COVER

    MDR report key: 2770180 · Received October 1, 2012

    Report

    Report Number
    2032593-2012-00064
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    SEASPINE, INC.
    Product Code
    ODP
    PMA / PMN Number
    K092521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORT NOTED: "THE ZUMA C COVER PLATE DISENGAGED FROM THE IMPLANT POST-OP". ADD'L INFO WAS RECEIVED. THE REPORTER STATED "THE INITIAL SURGERY WAS PERFORMED IN (B)(6) 2012. THE COVER PLATE WAS DISCOVERED TO START TO DISENGAGE FROM THE ZUMA C IMPLANT ON X-RAY IMAGES TAKEN DURING A POST-OPERATIVE ROUTINE F/U APPOINTMENT. THE PT HAS HAD A SECOND F/U AND THE X-RAY SHOWED THE COVER PLATE HAS UNTHREADED SLIGHTLY MORE. THE COVER PLATE ISN'T COMPLETELY DISENGAGED FROM THE ZUMA-C IMPLANT. THE DOCTOR IS 'WATCHING IT FOR NOW'. NO REVISION SURGERY HAS BEEN SCHEDULED TO DATE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PT TO DATE. NO PT WAS SENT FOR INVESTIGATION BECAUSE THERE HASN'T BEEN A REVISION SURGERY YET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZUMA-C LOCKING COVER ZUMA-C ODP SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1