BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 85MM

    MDR report key: 7630036 · Received June 22, 2018

    Report

    Report Number
    8030965-2018-54534
    Event Type
    Injury
    Date Received
    June 22, 2018
    Report Date
    May 28, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819268975
    PMA / PMN Number
    K023941
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF NON-UNION IS UNKNOWN DATE SUBSEQUENT TO (B)(6) 2017. DEVICE HAS NOT BEEN EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER EMAIL ADDRESS IS UNKNOWN. PART: 413.385S; LOT: L241461; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE DATE: DECEMBER 19, 2016; EXPIRY DATE: DECEMBER 01, 2026; THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING / STERILIZATION 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. 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. AS THERE IS NO DEVICE MALFUNCTION ALLEGED AND NO ASSOCIATED SURGICAL TECHNIQUE ERROR, A DCRM REVIEW WILL NOT BE COMPLETED AS IT IS OUTSIDE OF THE SCOPE OF THE DCRM. 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. 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 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 LEFT KNEE ON (B)(6) 2017. THE SURGERY WAS COMPLETED WITHOUT A DELAY. POST-OPERATIVELY, THE PATIENT¿S BONE UNION HAS BEEN SLOWER THAN EXPECTED. THROUGH THE X-RAYS TAKEN IN (B)(6) 2018, A GAP WAS NOTICED AROUND THE ARTIFICIAL JOINT. THIS COMPLAINT IS RELATED TO (B)(4), WHICH ACCOUNTS FOR THE RIGHT KNEE OF THE SAME PATIENT. THIS REPORT IS FOR A. 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 85MM. THIS IS REPORT 9 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472441 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 85MM APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L241461 07611819268975

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention