BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 4MM

    MDR report key: 3790503 · Received May 5, 2014

    Report

    Report Number
    2520274-2014-11242
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 8, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    PK042365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT IDENTIFIER NUMBER: (B)(6). DATE OF EVENT IS UNKNOWN. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED REGARDING A REVISION SURGERY DUE TO INFECTION. THE PATIENT ORIGINALLY UNDERWENT A CRANIOPLASTY PROCEDURE ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT PRESENTED WITH SWELLING, TENDERNESS, PAIN AND REDNESS. IT WAS REPORTED THAT THE SURGEON VISUALLY CONFIRMED THAT THE PATIENT DEVELOPED AN INFECTION. THE INFECTION WAS CULTURED BUT THE TYPE OF INFECTION IS UNKNOWN. THE SURGEON EXPLANTED ALL HARDWARE ON (B)(6) 2014, WHICH INCLUDED A CUSTOMIZED POLYETHERETHERKETONE (PEEK) IMPLANT, 4-MATRIXNEURO PLATES AND 16-MATRIXNEURO SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 7 OF 21 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268818 TI MATRIXNEURO SCREW SELF-DRILLING 4MM BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention