BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3894052 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-12115
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 28, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL DEVICE INFO: THIS REPORT IS FOR 1 BROKEN SCREW, PART AND LOT NUMBER UNKNOWN. (B)(4). 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 SURGEON WAS REMOVING A PLATE, FOR AN UNKNOWN REASON, AND WHEN THE SURGEON ATTEMPTED TO EXTRACT ONE OF THE SCREWS THE SCREW HEAD BROKE AT THE RECESS. THE SURGEON SCRAPED THE SCREW HEAD AND LEFT THE PLATE IN THE PATIENT. THE SURGEON REPORTED THAT THE SCREW WAS NOT EXTRACTED FORCIBLY. THIS REPORT IS FOR 1 BROKEN SCREW, PART AND LOT NUMBER UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371709 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention