BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4706485 · Received April 20, 2015

    Report

    Report Number
    2520274-2015-13145
    Event Type
    Injury
    Date Received
    April 20, 2015
    Report Date
    April 13, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. HEDEQUIST, D., MD, BISHOP, J., MD, HRESKO, T., MD. LOCKING PLATE FIXATION FOR PEDIATRIC FEMUR FRACTURES. J PEDIATR ORTHOP, VOL. 28, 1, JANUARY/FEBRUARY 2008. THIS REPORT IS FOR AN UNKNOWN 4.5-MM LOCKED COMPRESSION PLATES AND LESS INVASIVE STABILIZATION SYSTEM. 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: HEDEQUIST, D., MD, BISHOP, J., MD, HRESKO, T., MD. LOCKING PLATE FIXATION FOR PEDIATRIC FEMUR FRACTURES. J PEDIATR ORTHOP, VOL. 28, 1, JANUARY/FEBRUARY 2008. A RETROSPECTIVE REVIEW OF CHILDREN AT OUR INSTITUTION TREATED WITH A LOCKING PLATE FOR A FEMUR FRACTURE. WE IDENTIFIED 32 PATIENTS TREATED AT AN AVERAGE AGE OF 11 YEARS (RANGE 6-15 YEARS OF AGE). LOCKING PLATES WERE CHOSEN FOR COMMINUTION IN 13 PATIENTS, NONMALIGNANT PATHOLOGIC FRACTURE IN 9 PATIENTS, FRACTURE LOCATION IN 7 PATIENTS, AND OSTEOPENIA IN 3 PATIENTS. ALL PATIENTS WERE TREATED WITH THE EXCEPTION OF ONE WERE STAINLESS 4.5-MM LOCKED COMPRESSION PLATES (SYNTHES), THE OTHER PLATE WAS FROM SYNTHES LESS INVASIVE STABILIZATION SYSTEM (SYNTHES). COMPLICATION:1-VALGUS MALALIGNMENT, 7-PLATES REMOVED WITH NO NOTED COMPLICATION. THIS REPORT IS FOR AN UNKNOWN 4.5-MM LOCKED COMPRESSION PLATES AND LESS INVASIVE STABILIZATION SYSTEM (SYNTHES USA). THIS IS REPORT OF 1 OF 1 FOR COMPLAINT (B)(4). THIS REPORT IS FOR THE SERIOUS INJURY OF 8 PATIENTS THAT EXPERIENCE: 1-VALGUS MALALIGNMENT, 7-PLATES REMOVED WITH NO NOTED COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261437 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention