BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI CORTEX SCREW SELF-TAPPING 6MM

    MDR report key: 2772062 · Received September 28, 2012

    Report

    Report Number
    1719045-2012-00989
    Event Type
    Injury
    Date Received
    September 28, 2012
    Report Date
    August 31, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQN
    PMA / PMN Number
    K981275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE:DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH TWO (2) 2.4MM TI COMPRESSION TENSION AND PLATES AND TWELVE (12) SCREWS ON (B)(6) 2012. POSTOPERATIVELY, THE PT EXPERIENCED PAIN AND DRAINAGE. ON (B)(6) 2012, THE PT WAS RETURNED TO SURGERY FOR REMOVAL OF ALL HARDWARE. NO NEW HARDWARE WAS IMPLANTED AS IT WAS NOTED THAT THE FRACTURE WAS HEALED. THIS REPORT IS #2 OF 14 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4MM TI CORTEX SCREW SELF-TAPPING 6MM 2.4MM TI CORTEX SCREW SELF-TAPPING 6MM MQN SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention SCREWS| PLATES