BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3749482 · Received April 14, 2014

    Report

    Report Number
    2520274-2014-10830
    Event Type
    Injury
    Date Received
    April 14, 2014
    Report Date
    April 2, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DITSIOS, K., ET AL (2013). ¿FLOATING ELBOW INJURIES IN ADULTS: PROGNOSTIC FACTORS AFFECTING CLINICAL OUTCOMES.¿ JOURNAL OF SHOULDER ELBOW SURGERY, 22, 74-80. THIS REPORT IS FOR AN UNKNOWN PLATES/UNKNOWN LOT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, ¿FLOATING ELBOW INJURIES IN ADULTS: PROGNOSTIC FACTORS AFFECTING CLINICAL OUTCOMES.¿ DITSIOS, K., ET AL (2013). JOURNAL OF SHOULDER ELBOW SURGERY, 22, 74-80. BETWEEN DECEMBER 2002 AND JANUARY 2009, 19 PATIENTS WHO SUSTAINED FLOATING ELBOW INJURY WERE TREATED IN OUR ORTHOPEDIC DEPARTMENT. THE COHORT COMPRISED 19 PATIENTS (16 MEN AND 3 WOMEN) WHO WERE A MEAN AGE OF 33.7 YEARS (RANGE, 17-55 YEARS). A 28 YEAR OLD PATIENT WAS TREATED WITH INTERNAL FIXATION OF HUMERUS WITH A LOCKING COMPRESSION PLATE (LCP 4.5-MM) (SYNTHES, (B)(4)) AND THEN WITH ORIF OF ELBOW FRACTURES. SUBSEQUENTLY, THE PATIENT EXPERIENCED RADIAL NERVE PALSY. ALTHOUGH RADIAL NERVE EXPLORATION DID NOT SHOW ANY SIGNIFICANT LESION, THE NERVE DID NOT REGAIN FUNCTION DURING THE FIRST YEAR OF FOLLOW-UP. FLEXOR TENDONS TRANSFER WAS PERFORMED TO RESTORE WRIST AND DIGITS EXTENSION AT 11 MONTHS (ALSO REPORTED AS 15 MONTHS) AFTER INITIAL INJURY. IT WAS CONCLUDED THAT ALTHOUGH THE NATURE OF FLOATING ELBOW INJURIES IS COMPLEX, THE PRESENCE OF NERVE INJURY AND INTRA-ARTICULAR INVOLVEMENT PREDISPOSE TO WORSE CLINICAL OUTCOMES. THIS REPORT IS FOR AN UNKNOWN LCP PLATE. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226313 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention