BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø5 SELF-TAP L34 TAN

    MDR report key: 3243086 · Received July 23, 2013

    Report

    Report Number
    8030965-2013-04394
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    October 3, 2012
    Report Date
    June 27, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHAT LOT AND PART NUMBERS WERE INVOLVED IN THIS EVENT. THE PART AND LOT REPORTED IN THE INITIAL MEDWATCH IS ONE OF THREE COMBINATIONS PROVIDED. THE OTHER TWO POSSIBLE DEVICES INVOLVED WERE PART 413.332S LOT 2770656 AND PART 413.334S LOT 2766123.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PATIENT HAD A AO TYPE 41B1 (RIGHT). THE SURGEON CONDUCTED AN OPEN REDUCTION INTERNAL FIXATION (ORIF) FOR AO TYPE 41B1 ON (B)(6) 2011. AFTER THE BONE HEALED, THE SURGEON TRIED TO EXTRACT THE DEVICES (B)(6) 2012. HE COULD NOT EXTRACT TWO LOCKING SCREWS IN THE SHAFT AND THEY REMAINED IN THE PATIENTS BODY. IN (B)(6) 2013, THE PATIENT EXPRESSED CONCERN TO THE SURGEON AS TO WHY THE DEVICES COULD NOT BE REMOVED AND THE EFFECT ON HER HEALTH. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343759 LOCKSCR Ø5 SELF-TAP L34 TAN KTT SYNTHES GMBH 2745911

    Patients

    Seq Age Sex Outcome Treatment
    1