BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 8592596 · Received May 8, 2019

    Report

    Report Number
    8030965-2019-63659
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    September 29, 2014
    Report Date
    April 10, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) THIS REPORT IS FOR UNKNOWN SCREWS. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THIS REPORT IS FOR UNKNOWN SCREWS. PMA/510(K) NUMBER IS NOT AVAILABLE. PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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: FEI, W. ET AL (2014), FREE VASCULARIZED MEDIAL FEMORAL CONDYLE CORTICOCANCELLOUS FLAP FOR TREATMENT OF CHALLENGING UPPER EXTREMITY NONUNIONS, JOURNAL OF RECONSTRUCTIVE MICROSURGERY, VOL. 31, NO. 2, PAGES 124-131 (CHINA). THE AIM OF THIS STUDY IS TO DETERMINE THE EFFECTIVITY OF FREE VASCULARIZED MFC CORTICOCANCELLOUS FLAP TO PATIENTS WITH CHALLENGING UPPER EXTREMITY NONUNIONS AND SMALL BONE DEFECTS. BETWEEN JANUARY 2012 TO DECEMBER 2013, A TOTAL OF 15 PATIENTS (12 MALE AND 3 FEMALE) WITH A MEAN AGE OF 35 YEARS (RANGE 18-56 YEARS) WERE INCLUDED IN THIS STUDY. THERE WERE 12 ATROPHIC NONUNIONS AND 3 HYPERTROPHIC NONUNIONS. THE MEAN TIME FROM FRACTURE TO THE FREE MFC FLAP RECONSTRUCTION WAS 10 MONTHS (RANGE, 8¿15 MONTHS). THE MEAN NUMBER OF PREVIOUS PROCEDURES WAS 1.5 (RANGE, 0¿3) INCLUDING THE USE OF BONE GRAFTING (AUTOGRAFT/ALLOGRAFT), BONE STIMULATOR (ELECTRIC STIMULATION/ ULTRASOUND), AND GROWTH FACTOR INJECTION. ALL 13 PATIENTS WENT ON TO BONY UNION AT AN AVERAGE OF 15 WEEKS (RANGE, 8¿22 WEEKS) (TABLE 1 AND FIGS. 5¿9). THE MEAN FOLLOW-UP AFTER FREE MFC RECONSTRUCTION WAS 12 MONTHS (RANGE 4-19 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR-OLD MALE (PATIENT 1) HAD A 5 DEGREE LIMITATION OF ACTIVE SUPINATION AND 15 DEGREE LIMITATION OF ACTIVE PRONATION. 1 PATIENT DEVELOPED A HEMATOMA AT THE FLAP DONOR SITE. THIS REPORT IS FOR UNKNOWN SCREWS. IT CAPTURES 1 PATIENT DEVELOPED A HEMATOMA AT THE FLAP DONOR SITE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383016 SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention