BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 6853246 · Received September 8, 2017

    Report

    Report Number
    2520274-2017-12228
    Event Type
    Injury
    Date Received
    September 8, 2017
    Report Date
    August 24, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. FUKAO, S., KIDO, O., FUZOKU, T. AND LI, H. (2015) EXPERIENCE IN TREATMENT OF FRACTURES OF THE AXIAL ODONTOID PROCESS. SPINAL SURGERY, VOLUME 29: 95-97. THIS REPORT IS FOR UNKNOWN - CANNULATED SCREW (3.5MM CALIBER AND 40MM LENGTH)/UNKNOWN QUANTITY/UNKNOWN LOT. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. PART # IS UNKNOWN, 510K IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ABSTRACT FUKAO, S., KIDO, O., FUZOKU, T. AND LI, H. (2015) EXPERIENCE IN TREATMENT OF FRACTURES OF THE AXIAL ODONTOID PROCESS. SPINAL SURGERY, VOLUME 29: 95-97. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO EXAMINE THE ADAPTATION AND LIMITATION OF THE PROCEDURE IN WHICH AN ANTERIOR SCREW FIXATION IS USED TO TREAT UNSTABLE TYPE II FRACTURES OF THE ODONTOID PROCESS AND PRESENT RESULTS OF THIS TREATMENT. THIS STUDY WAS PERFORMED FROM MARCH 2011 TO FEBRUARY 2014. THE STUDY INCLUDED SIX (6) PATIENTS WITH AGE RANGING FROM 66 TO 97-YEAR-OLD, WITH THE AVERAGE AGE BEING 82-YEAR-OLD. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN - CANNULATED SCREW (3.5MM CALIBER AND 40MM LENGTH) AND REFERS TO (B)(6) WHO HAD NECK PAIN DECREASE HOWEVER, LOOSENING OF THE SCREW WAS DETECTED WITH SIMPLE X-RAY AFTER 1 MONTH. PATIENT DIED OF CHOLANGIOCARCINOMA 3 MONTHS AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631679 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention