BEUDAMED
    FDA Adverse Event Death Summary report: N

    4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 14MM

    MDR report key: 3910534 · Received July 2, 2014

    Report

    Report Number
    2520274-2014-12329
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 5, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    PMA / PMN Number
    PK031276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT'S LAST NAME: (B)(6). 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 THE PATIENT WAS IMPLANTED ON (B)(6) 2014, AT LEVELS C4-C7 WITH AN ANTERIOR CERVICAL PLATE AND NON SYNTHES ALLOGRAFT BONE CAGES. THE PATIENT¿S DEATH OCCURRED ON (B)(6) 2014, WITH POSSIBLE RELATION TO A HEMATOMA IN NECK. THE CAUSE OF DEATH IS UNCONFIRMED. THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND WILL NOT BE RETURNED. THIS IS REPORT 2 OF 17 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387645 4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 14MM APPLIANCE FIXATION SPINAL INTERVERTEBRAL BODY KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death