BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.9MM TI MATRIXRIB LCKNG SCREWSELF-TAPPING/12MM

    MDR report key: 3260286 · Received August 1, 2013

    Report

    Report Number
    2520274-2013-04780
    Event Type
    Injury
    Date Received
    August 1, 2013
    Report Date
    July 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K081623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

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

    Description of Event or Problem · 1

    PATIENT UNDERWENT TREATMENT AND WAS IMPLANTED WITH MATRIXRIB DEVICES AFTER A CRUSH INJURY WITH NON-UNION IN (B)(6) 2010. ON (B)(6) 2012, PATIENT WAS REVISED TO AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF RIBS 3 THROUGH 5. THE PATIENT DEVELOPED AN INFECTION THAT REQUIRED PLATE REMOVAL ON (B)(6) 2012, AND A REPEAT ORIF WAS PERFORMED SUCCESSFULLY. THIS IS REPORT 14 OF 31 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360800 2.9MM TI MATRIXRIB LCKNG SCREWSELF-TAPPING/12MM HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention