BEUDAMED
    FDA Adverse Event Other Summary report: N

    TI SCR CLICK OFF 12X20 MM EACH

    MDR report key: 4620020 · Received March 18, 2015

    Report

    Report Number
    9613350-2015-00336
    Event Type
    Other
    Date Received
    March 18, 2015
    Date of Event
    February 17, 2015
    Report Date
    February 17, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TI SCR CLICK OFF 12X20 MM EACH FRACTURED DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185083 TI SCR CLICK OFF 12X20 MM EACH CLICK OFF SCREWS HWC NORMED MEDIZIN-TECHNIK GMBH NA 8728/269811

    Patients

    Seq Age Sex Outcome Treatment
    1 Other