BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3791914 · Received May 6, 2014

    Report

    Report Number
    2520274-2014-11265
    Event Type
    Injury
    Date Received
    May 6, 2014
    Report Date
    April 8, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 4 SET SCREWS AND 4 QUICK SCREWS UNKNOWN PART AND LOT NUMBERS 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272362 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention