BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOCKING SCREW

    MDR report key: 2880850 · Received December 20, 2012

    Report

    Report Number
    1719045-2012-01409
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MNI
    PMA / PMN Number
    K091689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. STERILIZATION VALIDATION DOCUMENTATION, DECISION FINDING PROTOCOLS, DFPS, WAS REVIEWED AND DEMONSTRATED THAT EACH OF THE PART NUMBERS INCLUDED WITHIN THIS COMPLAINT HAD BEEN EVALUATED FOR STERILIZATION. THE STERILIZATION PARAMETERS ARE CONSISTENT WITH SYNTHES CURRENT IFUS, AND THE SUPPORTING VALIDATIONS DEMONSTRATE THAT A (B)(4) IS ACHIEVABLE WHEN THE IFUS ARE EMPLOYED. 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 HARDWARE ON (B)(6) 2012. PATIENT DEVELOPED AN INFECTION. ON (B)(6) 2012, THE SURGEON DID A RINSE OUT DUE TO THE PATIENTS INFECTION. THE SURGEON WENT DEEP ENOUGH INTO THE WOUND AND WAS ABLE TO SEE THE SCREW. THE SURGEON WAS NOT SATISFIED WITH THE POSITIONING OF THE SCREW. THE SURGEON THEN REMOVED THE SCREW AND THE LOCKING CAP. THE SALES CONSULTANT BELIEVES THE AREA WAS AT C2-T3 LEVELS. THE SURGEON DID NOT REPLACE THE HARDWARE. THIS IS 2 OF 34 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI LOCKING SCREW TI LOCKING SCREW MNI SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RODS, SCREWS