BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

    MDR report key: 8500791 · Received April 10, 2019

    Report

    Report Number
    8030965-2019-62673
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Report Date
    March 19, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819760592
    PMA / PMN Number
    K122455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: LXT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: REPORTER IS SYNTHES SALES CONSULTANT. 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. 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 ON AN UNKNOWN DATE, THE SCREW OF THE SELF-HOLDING CLAMP WAS LOOSEN AND THE NUT WAS UNMOVABLE. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291540 LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL APPLIANCE,FIXATION,NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 1531623 07611819760592

    Patients

    Seq Age Sex Outcome Treatment
    1