BEUDAMED
    FDA Adverse Event Death Summary report: N

    1.8MM TI LOCKING SCREW

    MDR report key: 3910582 · Received July 2, 2014

    Report

    Report Number
    2520274-2014-12336
    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. (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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES) WAS CHECKED IN ERROR. 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 8 OF 17 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388497 1.8MM TI LOCKING SCREW APPLIANCE FIXATION SPINAL INTERVERTEBRAL BODY KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death| R