BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.8MM TI LOCKING SCREW

    MDR report key: 2923916 · Received January 22, 2013

    Report

    Report Number
    2520274-2013-00482
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 26, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    PMA / PMN Number
    K994187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH CERVICAL PLATE AND SCREW CONSTRUCT AT C5-C7 ON (B)(6) 1998. ON AN UNKNOWN POST-OPERATIVE DATE, PATIENT EXPERIENCED STIFFNESS IN UPPER NECK, HAND NUMBNESS, GRIP WEAKNESS, AND DULL NECK ACHE. PATIENT RETURNED TO THE OR ON (B)(6) 2012 AND ALL HARDWARE WAS REMOVED. SUBSEQUENTLY, THE SURGEON FUSED THE PATIENT POSTERIORLY C2-T2. THIS IS 7 OF 9 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31276 1.8MM TI LOCKING SCREW SCREW MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention PLATE