BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4688844 · Received April 14, 2015

    Report

    Report Number
    2520274-2015-12662
    Event Type
    Injury
    Date Received
    April 14, 2015
    Date of Event
    March 31, 2007
    Report Date
    March 25, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATE SYSTEM/UNKNOWN QUANTITY/UNKNOWN LOT. PERTAINS TO POOR SHOULDER FUNCTION. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 LITERATURE ARTICLE, JIANG, R., LOU, C., ZENG, B. AND MEI, G. (2007). MINIMALLY INVASIVE PLATING FOR COMPLEX HUMERAL SHAFT FRACTURES. ARCH ORTHOP TRAUMA SURG, 127, 531-535. THE AUTHORS EVALUATED THE CLINICAL AND RADIOGRAPHIC OUTCOMES OF TREATING COMPLEX HUMERAL SHAFT FRACTURES BY USING SYNTHES DEVICE, LOCKING COMPRESSION PLATE (LCP) SYSTEM WITH MINIMALLY INVASIVE TECHNIQUE. FROM (B)(6) 2003 TO (B)(6) 2004, 22 CASES WITH ACUTE COMPLEX HUMERAL SHAFT FRACTURES WERE TREATED. ONE PATIENT DIED OF OTHER INJURES; THEREFORE, 21 PATIENTS, SEVEN WOMEN AND 14 MEN WITH AGE 42.9 YEARS (RANGE, 18-75 YEARS), WERE TREATED. ROUTINE RADIOGRAPHS AND CLINICAL EVALUATION WERE PERFORMED; AVERAGE FOLLOW-UP WAS 28.7 MONTHS (RANGE, 19-37 MONTHS). RESULTS INCLUDED: NONUNION IN TWO PATIENTS WITH SECONDARY ILIAC CREST AUTO GRAFTING IN ORDER TO ACHIEVE UNION; POOR SHOULDER FUNCTION (THREE). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247491 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention