BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINICA CERVICAL PLATE 1 LEVEL 26MM

    MDR report key: 2051359 · Received April 7, 2011

    Report

    Report Number
    2184052-2011-00003
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ZIMMER SPINE
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED FROM THE FACILITY AND THE SURGEON BUT NONE HAS BEEN RECEIVED AT PRESENT. INITIAL INFO DOES NOT INDICATE A CAUSE OF THE INFECTION; THEREFORE, THE REPORT IS BEING SUBMITTED BECAUSE THE RELATIONSHIP OF THE EVENT TO THE DEVICE CAN NOT BE RULED OUT. ADDITIONAL RELEVANT INFO WILL BE PROVIDED AS RECEIVED. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNK AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NINE DAYS POST SURGERY, AN INFECTION AT THE INCISION SITE WAS OBSERVED. THE TRINICA PLATES AND SCREWS WERE REMOVED AND REPLACED. THE PT STATUS AT 10 DAYS POST-REVISION IS STABLE/NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINICA CERVICAL PLATE 1 LEVEL 26MM CERVICAL PLATE KWQ ZIMMER SPINE 07.00340.003 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TRINICA CERVICAL 2 LEVEL PLATE 36MM,| PART# 07.00811.007| (6) TRINICA SELF DRILLING VARIABLE SCREW 4.2X14MM,| (2) TRINICA SELF DRILLING VARIABLE SCREW 4.2X16MM,| PART# 07.00812.005| PART# 07.00341.009