BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINICAN TI SCR CANN 3.5X40 MM P THD

    MDR report key: 4617222 · Received March 17, 2015

    Report

    Report Number
    9613350-2015-00331
    Event Type
    Other
    Date Received
    March 17, 2015
    Date of Event
    February 17, 2015
    Report Date
    February 17, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    HRS
    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 INFO PROVIDED. SHOULD ADD'L INFO 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 THE SCREW MINICAN TI SCR CANN 3.5X40 MM P THD BROKE WHEN ENTERING IN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180821 MINICAN TI SCR CANN 3.5X40 MM P THD NORMED TITANIUM OSTEOTOMY PLATING SYSTEM HRS NORMED MEDIZIN-TECHNIK GMBH NA 13073/185B13

    Patients

    Seq Age Sex Outcome Treatment
    1 Other