BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINICA SCREW SELF-DRILLING VARIABLE 4.2X14

    MDR report key: 2431041 · Received January 26, 2012

    Report

    Report Number
    2184052-2012-00002
    Event Type
    Injury
    Date Received
    January 26, 2012
    Date of Event
    December 29, 2011
    Report Date
    December 30, 2011
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K012305
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT PRESENTED WITH NECK PAIN APPROXIMATELY 22 MONTHS POST-OP. X-RAYS SHOWED BROKEN SCREWS AT C3 AND C6. THE CONSTRUCT WAS REMOVED HOWEVER THE TWO BROKEN SCREW TIPS REMAIN IN THE VERTEBRAL BODY AT C3 AND C6. THE PT WAS REVISED WITH A DIFFERENT DEVICE. NO FURTHER PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRINICA SCREW SELF-DRILLING VARIABLE 4.2X14 TRINICA SCREW SELF-DRILLING VARIABLE KWQ ZIMMER SPINE, INC. 07.00812.005 61189062

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention