BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI TOMOFIX(TM) MEDIAL HIGH TIBIA PLATE 4 HOLES

    MDR report key: 9439969 · Received December 9, 2019

    Report

    Report Number
    8030965-2019-70950
    Event Type
    Injury
    Date Received
    December 9, 2019
    Report Date
    November 21, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819245761
    PMA / PMN Number
    K023941
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. DEVICE HISTORY: PART: 440.834S, LOT: 8234083, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 04. FEB. 2013, EXPIRY DATE: 01. JAN. 2023. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/ OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT A HIGH TIBIAL OSTEOTOMY USING THE TOMOFIX TIBIAL HEAD PLATE. ABOUT 6 YEARS AFTER THE SURGERY, THE PATIENT¿S SKIN AROUND THE IMPLANT BECAME LIKE A CUTANEOUS DISEASE. IT WAS LIKE THE SYMPTOM OF METAL ALLERGY. THE PATIENT UNDERWENT A REMOVAL SURGERY ON (B)(6) 2019. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233428 TI TOMOFIX(TM) MEDIAL HIGH TIBIA PLATE 4 HOLES APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 8234083 07611819245761

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention