BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 8615254 · Received May 16, 2019

    Report

    Report Number
    8030965-2019-64008
    Event Type
    Injury
    Date Received
    May 16, 2019
    Report Date
    April 18, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN THIRD TUBULAR AO PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: PATRICK VIENNE (2005), INTERPOSITION ARTHRODESIS OF THE ANKLE, OPERATIVE ORTHOPADIE AND TRAUMATOLOGY VOL. 17(4-5), PAGES 502-517 (SWITZERLAND) DOI 10.1007/S00064-005-1141-Y. THE AIM OF THIS ARTICLE IS TO CHECK THE BONY FUSION OF THE ANKLE IN A FUNCTIONALLY FAVORABLE POSITION FOR RESTITUTION OF A PAINLESS WEIGHT BEARING WHILE AVOIDING A LEG LENGTH DISCREPANCY. BETWEEN JANUARY 2002 TO JANUARY 2004, A TOTAL OF 5 PATIENTS (1 MALE AND 4 FEMALE) WITH A MEAN AGE OF 57 YEARS (RANGE, 42-77 YEARS) WERE INCLUDED IN THE STUDY. THESE PATIENTS HAD SEVERE BONE DEFECTS OD THE ANKLE AND WERE TREATED WITH A 6.5MM AND 3.5MM AO TITANIUM SCREWS, 3RD TUBULAR TITANIUM AO PLATES. THE MEAN DURATION OF FOLLOW-UP WAS 25 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PATIENT (B)(6) A (B)(6) YEAR-OLD FEMALE HAD NONUNION, SUBSIDENCE OF THE BONE GRAFT. BREAKAGE OF THE IMPLANTS WHICH LEADS TO A REVISION ARTHRODESIS WITH NAIL WAS REQUIRED. THIS REPORT IS FOR AN UNKNOWN THIRD TUBULAR AO PLATE. THIS IS REPORT 3 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411478 PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention