BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4213455 · Received October 30, 2014

    Report

    Report Number
    2520274-2014-14356
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    October 3, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FOR TREATMENT, NOT DIAGNOSIS SHOULDER FUNCTION AFTER SURGICAL TREATMENT OF DISPLACED FRACTURES OF THE HUMERAL SHAFT: A RANDOMIZED TRIAL COMPARING ANTEGRADE INTRAMEDULLARY NAILING WITH MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS. BENEGAS, E. PHD, NETO, AAF. PHD, GRACITELLI, MEC, MD, MALAVOLTA, EA, MD, ASSUNCAO, JH, MD, PRADA, FD, MD, NETO, RB, PHD, MATTAR JR, R, PHD. J SHOULDER ELBOW SURG. (2014) THIS REPORT IS FOR AN UNKNOWN-COMPRESSION PLATE. THE EVENT OF 2 SYMPTOMATIC SHOULDER STIFFNESS WERE TREATED WITH PHYSICAL THERAPY. 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, SHOULDER FUNCTION AFTER SURGICAL TREATMENT OF DISPLACED FRACTURES OF THE HUMERAL SHAFT: A RANDOMIZED TRIAL COMPARING ANTEGRADE INTRAMEDULLARY NAILING WITH MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS. BENEGAS, E. PHD, NETO, AAF. PHD, GRACITELLI, MEC, MD, MALAVOLTA, EA, MD, ASSUNCAO, JH, MD, PRADA, FD, MD, NETO, RB, PHD, MATTAR JR, R, PHD. J SHOULDER ELBOW SURG. (2014) 23, 767-774. A PROSPECTIVE RANDOMIZED STUDY WAS PERFORMED. PATIENTS WERE ALLOCATED TO 2 GROUPS BY A SIMPLE RANDOMIZATION STRATEGY. THE RANDOMIZATION WAS PERFORMED BY AN ASSISTANT WHO DIDN¿T PARTICIPATE IN THE SURGICAL PROCEDURE. THE TWO GROUPS CONSISTED OF MIPO (21 PATIENTS) AND THE IMN (19 PATIENTS). FORTY ¿ONE HUMERAL SHAFT FRACTURES (40 PATIENTS) WERE RANDOMIZED TO BE TREATED WITH A MINIMALLY INVASIVE PLATE OR A LOCKING INTRAMEDULLARY NAIL. CLINICAL AND RADIOGRAPHIC OUTCOME ASSESSMENTS WERE CONDUCTED AT 1 YEAR POSTOPERATIVELY. COMPLICATIONS: IN THE MIPO GROUP: 1 DEEP WOUND INFECTION REQUIRED DEBRIDEMENT , 2 SYMPTOMATIC SHOULDER STIFFNESS WERE TREATED WITH PHYSICAL THERAPY. COMPLICATIONS: IN THE IMN GROUP: 1 NONUNION. THIS REPORT IS FOR AN UNKNOWN-COMPRESSION PLATE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696215 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention