BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-TEK IVP PLT S 0 MM OS RT 2.7

    MDR report key: 4617202 · Received March 16, 2015

    Report

    Report Number
    9613350-2015-00324
    Event Type
    Other
    Date Received
    March 16, 2015
    Date of Event
    February 19, 2015
    Report Date
    February 19, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW AS THE PT HAS NOT BEEN REVISED. 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 A V-TEK IVP PLT S 0 MM OS RT 2.7 WAS IMPLANTED ON (B)(6) 2012. SINCE SURGERY THE PT HAS SUFFERED FROM DISCOMFORT LIKE SWELLINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178070 V-TEK IVP PLT S 0 MM OS RT 2.7 NORMED TITANIUM OSTEOTOMY PLATING SYSTEM HRS NORMED MEDIZIN-TECHNIK GMBH NA 11737

    Patients

    Seq Age Sex Outcome Treatment
    1 Other