BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 24MM

    MDR report key: 7631400 · Received June 22, 2018

    Report

    Report Number
    8030965-2018-54561
    Event Type
    Injury
    Date Received
    June 22, 2018
    Report Date
    May 28, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819268777
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID/INITIALS AND WEIGHT ARE UNKNOWN. DATE OF EVENT: UNKNOWN. EXPLANTED DATE: DEVICE HAS NOT BEEN EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PART 413.324S, LOT 9221980: MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: NOVEMBER 06, 2014. EXPIRY DATE: OCTOBER 01, 2024. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: REVIEWING THE X-RAY PICTURES IT CAN BE CONFIRMED THAT THERE IS STILL A GAP AND NON-UNION CAN BE IDENTIFIED. THERE IS NO ALLEGATION OF DEVICE DEFECT, DEFICIENCY OR SURGICAL TECHNIQUE ERROR ASSOCIATED WITH THIS COMPLAINT. PRODUCT WAS NOT RETURNED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE OPEN WEDGE HIGH TIBIAL OSTEOTOMY WAS APPLIED TO GONARTHROSIS IN THE RIGHT KNEE ON (B)(6) 2017. THE PATIENT¿S BONE UNION HAD BEEN SLOWER THAN EXPECTED. IT IS CERTAIN THROUGH THE X-RAYS THAT A GAP WAS NOTICED AROUND THE ARTIFICIAL JOINT. ACCORDING TO THE X-RAYS, IT IS LIKELY THAT THE PATIENT HAS SUFFERED FROM HINGE FRACTURES, TOO. IT WAS NOTED THE PATIENT FEELS PAIN IN THE KNEE WHILE DRIVING. IN (B)(6) 2018, IT IS PLANNED THAT THE PATIENT WILL UNDERGO HIGH TIBIAL OSTEOTOMY IN THE LEFT KNEE. IN THAT UPCOMING SURGERY, THE SURGEON IS PLANNING A REVISION SURGERY IN THE RIGHT KNEE, TOO. THIS IS REPORT 8 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471284 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 24MM APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 9221980 07611819268777

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention