BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4242392 · Received November 11, 2014

    Report

    Report Number
    2520274-2014-14625
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR DYNAMIC LOCKING SCREWS, QUANTITY, PART AND LOT NUMBER UNKNOWN. (B)(4) POSSIBLE ALLERGIC REACTION WHICH CAN BE ASSUMED BY THE EVENT DESCRIPTION BUT HAS NOT BEEN VERIFIED. 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. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE PATIENT HAS THREE FISTULA´S AND THE SURGEON HAS HEARD RUMORS OF BROKEN DYNAMIC LOCKING SCREWS (DLS) AND IS AFRAID TO REMOVE THE SCREWS. PATIENT WAS TESTED POST-OPERATIVE AND HAS AN ALLERGY FOR COBALT CHROME. THIS REPORT IS FOR THE UNKNOWN DYNAMIC LOCKING SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727723 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention