BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXNEURO STRAIGHT PLATE 2 HOLES/9MM

    MDR report key: 3100382 · Received May 8, 2013

    Report

    Report Number
    2520274-2013-02429
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K042365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    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 COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PATIENT WAS IMPLANTED WITH A PEEK IMPLANT (SD DEVICE) FOR RIGHT TEMPORAL MENINGIOMA. DURING FOLLOW-UP ON AN UNKNOWN DATE, THE SURGEON NOTED THE PEEK IMPLANT WAS LOOSE. A CT SCAN SHOWED POSSIBLE RESORBTION OF THE BONE AROUND THE IMPLANT, CAUSING THE IMPLANT TO BECOME LOOSE. SURGEON PLANNED TO REPLACE IMPLANT WITH A NEW IMPLANT WHICH WILL COMPENSATE FOR RESORBING BONE. SURGEON USED A MATRIX NEURO PLATE AND SCREWS TO FIXATE THE IMPLANT IN THE SKULL TEMPORARILY. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO THE SURGEON COMPLAINING OF HEADACHE AND HARDWARE (PEEK IMPLANT) LOOSENING. REPORTEDLY THE PATIENT WAS TREATED FOR RIGHT TEMPORAL MENINGIOMA WHERE HIS ORIGINAL BONE FLAP RESORBED. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REVISION SURGERY. THE SURGEON REMOVED THE PEEK IMPLANT AND REVISED THE PATIENT TO A NEW PEEK IMPLANT. THIS IS 2 OF 5 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200560 TI MATRIXNEURO STRAIGHT PLATE 2 HOLES/9MM JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention