BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3813504 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11219
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SYNTHES(USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BOSCHI, V., ET AL (2013, FEBRUARY). SUBBRACHIAL APPROACH TO HUMERAL SHAFT FRACTURES: NEW SURGICAL TECHNIQUE AND RETROSPECTIVE CASE SERIES STUDY. CAN J SURG, 56 (1), 27-34. THIS REPORT IS FOR AN UNKNOWN PLATE. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, BOSCHI, V., ET AL (2013, FEBRUARY). SUBBRACHIAL APPROACH TO HUMERAL SHAFT FRACTURES: NEW SURGICAL TECHNIQUE AND RETROSPECTIVE CASE SERIES STUDY. CAN J SURG, 56 (1), 27-34. THE AUTHORS CONDUCTED A RETROSPECTIVE CASE SERIES INVOLVING PATIENTS WHO HAD SURGERY FOR A HUMERAL SHAFT FRACTURE BETWEEN JANUARY 1994 AND JANUARY 2008. PATIENTS WERE DIVIDED INTO FOUR GROUPS BASED ON SURGICAL APPROACH (ANTERIOR, ANTEROLATERAL, POSTERIOR, SUBBRACHIAL). TWO HUNDRED AND EIGHTY PATIENTS (70 PATIENTS IN EACH GROUP, ALL MALE, MEAN AGE 33.5 YEARS) UNDERWENT SURGERY AND WERE TREATED WITH A SYNTHES 4.5 MM DYNAMIC COMPRESSION PLATE (DCP). PATIENTS WERE FOLLOWED UP AT WEEK SIX AND AT MONTHS THREE, FOUR, SIX, EIGHT, 12, AND 24. UNION WAS ACHIEVED IN 98.2 PERCENT OF PATIENTS AND DELAYED UNION OCCURRED IN 1.8 PERCENT; NONUNION WAS NOT OBSERVED. OF THE 140 PATIENTS IN THE ANTEROLATERAL AND ANTERIOR GROUPS, ONE PATIENT EXPERIENCED A SECONDARY INFECTION. THE AUTHORS CONCLUDED THAT THE SUBBRACHIAL APPROACH IS PRACTICAL AND EFFECTIVE. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290532 PLATE, FIXATION, BONE HRS SYNTHES(USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention