BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 4140900 · Received October 3, 2014

    Report

    Report Number
    2520274-2014-13897
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 10, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN SWEDEN AS FOLLOWS: IT WAS REPORTED THAT AT FIXATION C5-C7. DURING SURGERY THERE WAS A TACTILE FEELING OF A GOOD BONE ATTACHMENT. IT WAS REPORTED THAT ON POSTOP X-RAY EVERYTHING LOOKED FINE; AND THE PATIENT WAS CURED FROM HER SYMPTOMS. DURING RETURN VISIT 8 WEEKS LATER, THE PATIENT IS STILL FEELING GOOD, BUT ON X-RAY THERE IS PULLOUT ON 4 OF 6 SCREWS. THIS REPORT IS FOR 4 UNKNOWN SCREWS. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619028 SCREW,FIXATION,BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR