BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 8MM

    MDR report key: 3812424 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11465
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    PK063790
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 THAT A REMOVAL OF AN ADAPTION PLATE WAS DUE TO A INFLAMMATORY RESPONSE AND INFECTION. IT WAS ALSO REPORTED THAT WHILE THE SURGEON WAS PERFORMING THE REVISION SURGERY, IT WAS NOTICED THAT THE CORTICAL SCREWS WOULD FULLY DETACH FROM THE BONE OR BE LOOSE. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF SCREWS. THIS REPORT IS FOR 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291793 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 8MM BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention