BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI COLLAR WITH GROOVES

    MDR report key: 2820945 · Received November 6, 2012

    Report

    Report Number
    2520274-2012-02938
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    MNH
    PMA / PMN Number
    K091689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 HAD A POSTERIOR LUMBAR FUSION, LEVEL L4 - S1, ON (B)(6) 2009, IMPLANTED WITH A USS CONSTRUCT. THE PATIENT DEVELOPED ADJACENT LEVEL DISC DISEASE AND STENOSIS AT THE L2-3, AND L3-4 LEVELS ABOVE THE PREVIOUS FUSION ON AN UNKNOWN DATE. ON (B)(6) 2012 PATIENT WAS RETURNED TO OR, THE USS HARDWARE WAS REMOVED, PATIENT WAS REVISED TO USS DUAL OPENING HARDWARE FROM LEVEL L2 - S1. IT WAS NOTED: THERE WERE NO ISSUES WITH THE HARDWARE THAT WAS PLACED ON (B)(6) 2009. THIS IS 12 OF 20 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI COLLAR WITH GROOVES COLLAR WITH GROOVES MNH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SIDE OPENING SCREW, COLLAR, NUT, ROD