BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - EX-FIX: ELBOW HINGED

    MDR report key: 11650600 · Received April 12, 2021

    Report

    Report Number
    8030965-2021-02791
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 22, 2007
    Report Date
    March 15, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K063832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: LXT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SCHMICKAL T, HOENTZSCH D, WENTZENSEN A, HINGED EXTERNAL FIXATOR FOR EARLY FUNCTIONAL TREATMENT OF COMPLEX OSTEOLIGAMENTOUS INJURIES OF THE ELBOW JOINT, TRAUMA SURGEON 2007, VOLUME 110, PAGE 320¿326, (GERMANY) . FROM 1997 TO 2004, 23 PATIENTS WITH RECENT COMPLEX FRACTURES OF THE ELBOW JOINT AND WITH RESIDUAL OSTEOLIGAMENTOUS INSTABILITY FOLLOWING OSTEOSYNTHESIS AND LIGAMENT RECONSTRUCTION WERE GIVEN EARLY FUNCTIONAL FOLLOW-UP TREATMENT USING A HINGED EXTERNAL FIXATOR AND WERE INCLUDED IN THE STUDY. THE UNKNOWN AO HINGED EXTERNAL FIXATOR WAS USED FOR ALL PATIENTS. IN 21 OF THE CASES, OPEN RECONSTRUCTION WITH INTERNAL OSTEOSYNTHESIS WAS PERFORMED; REPLACEMENT OF THE RADIAL HEAD BY A RADIAL HEAD PROSTHESIS WAS NECESSARY IN 3 CASES AND RADIAL HEAD RESECTION IN 1 CASE. TREATMENT USING THE HINGED EXTERNAL FIXATOR WAS BEGUN AN AVERAGE 6.4 DAYS FOLLOWING THE SURGICAL STABILIZATION PROCEDURE, WAS DOCUMENTED AN AVERAGE OF 3.5 DAYS AFTER STARTING THE EARLY FUNCTIONAL TREATMENT. IN 2 PATIENTS, ACCOMPANYING ILLNESSES PREVENTED INTERNAL RECONSTRUCTION AND STABILIZATION FROM BEING CARRIED OUT, AND THEREFORE ONLY EARLY FUNCTIONAL TREATMENT OF THE FRACTURE USING THE UNKNOWN AO HINGED EXTERNAL FIXATOR WAS POSSIBLE IN THESE CASES. COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD SUPPLEMENTARY SPONGIOPLASTY ON THE ULNA BECAME NECESSARY DURING THE COURSE OF TREATMENT DUE TO DELAYED OSSEOUS CONSOLIDATION WITHOUT IMPLANT FAILURE. 1 PATIENT HAD A LOSS OF RANGE OF MOTION (ROM) BY 5 DEGREES. 4 PATIENTS HAD NO FUNCTIONAL IMPROVEMENT DURING THE COURSE OF THE EARLY FUNCTIONAL FOLLOW-UP TREATMENT. 1 PATIENT HAD AN EXTENSION DEFICIT OF 50 DEGREES AND FLEXION DEFICIT OF 30 DEGREES. 6 PATIENTS WERE UNABLE TO REGAIN ANY MORE ROM AFTER TREATMENT USING THE UNKNOWN AO HINGED EXTERNAL FIXATOR. 1 PATIENT HAD POOR CLINICAL RESULT WITH AN EXTENSION DEFICIT OF 80 DEGREES AND A FLEXION DEFICIT OF 15 DEGREES. THERE WAS AN AVERAGE EXTENSION DEFICIT OF 27.8 DEGREES AND AN AVERAGE FLEXION DEFICIT OF 15.4 DEGREES IN THE FOLLOW-UP TREATMENT RESULTS GATHERED AFTER 10 MONTHS ON AVERAGE. THIS REPORT IS FOR THE UNKNOWN AO HINGED EXTERNAL FIXATOR. THIS REPORT IS FOR ONE (1) UNK - EX-FIX: ELBOW HINGED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546563 UNK - EX-FIX: ELBOW HINGED APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1