BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIZIA 2-LEVEL ACDF PLATE - 42MM

    MDR report key: 3223853 · Received July 10, 2013

    Report

    Report Number
    2184052-2013-00024
    Event Type
    Injury
    Date Received
    July 10, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWQ
    PMA / PMN Number
    K111796
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS EXPECTED TO BE RETURNED BUT HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN PRODUCT EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2184052-2013-00023. IT WAS REPORTED THAT FOLLOWING SPINAL FUSION SURGERY, A CERVICAL PLATE LOCKING MECHANISM WAS BROKEN AND A SCREW WAS BROKEN AND BACKING OUT. AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT HAD A TWO LEVEL ACDF AT C4-C6 USING A 2 LEVEL INVIZIA CERVICAL PLATE AND SCREWS WITH TM-S INTERBODY DEVICES. FOLLOW UP IMAGING PERFORMED ABOUT 4 MONTHS POST-OPERATIVELY REVEALED NO ISSUES WITH THE CONSTRUCT. FOLLOW UP IMAGING PERFORMED 7 MONTHS POST-OPERATIVELY REVEALED THAT THE LOCKING MECHANISM OVER THE RIGHT C6 SCREW WAS BROKEN. A SHAFT BREAK WAS NOTED IN THE RIGHT C6 SCREW AND THE SCREW WAS BACKING OUT. C4-C5 WAS SOLIDLY FUSED WITH A TM-S INTERBODY. THE PATIENT WAS ASYMPTOMATIC AT THE TIME AND UNDERWENT REVISION SURGERY A WEEK LATER. THE INVIZIA PLATE AND SCREWS WERE REMOVED AND REPLACED. THE INTERBODY AT C5-C6 WAS ALSO REPLACED AT THAT TIME DUE TO OBSERVED INFERIOR PSEUDOARTHROSIS. THERE WAS NO KNOWN TRAUMA BUT THE PATIENT REPORTS GOING TO THE HAIRDRESSER PRIOR TO THE 7 MONTH VISIT. THE HAIRDRESSER PULLED/JERKED HER HEAD BACK DURING HER APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316046 INVIZIA 2-LEVEL ACDF PLATE - 42MM INVIZIA 2-LEVEL ACDF PLATE - 42MM KWQ ZIMMER SPINE 07.01616.005 61843864

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R