BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3790593 · Received May 5, 2014

    Report

    Report Number
    2520274-2014-11032
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 22, 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 FOR DIAGNOSIS. ADAM, P., BONNOMET, F., EHLINGER, M., (2012), ADVANTAGE AND LIMITATIONS OF A MINIMALLY-INVASIVE APPROACH AND EARLY WEIGHT BEARING IN THE TREATMENT OF TIBIAL SHAFT FRACTURES WITH LOCKING PLATES., ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, 98, 564-569. THIS REPORT IS FOR AN UNKNOWN ANATOMICAL LOCKING PLATES. 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: ADAM, P., BONNOMET, F., EHLINGER, M., (2012), ADVANTAGE AND LIMITATIONS OF A MINIMALLY-INVASIVE APPROACH AND EARLY WEIGHT BEARING IN THE TREATMENT OF TIBIAL SHAFT FRACTURES WITH LOCKING PLATES., ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, 98, 564-569. INTRAMEDULLARY NAILING IS A COMMON METHOD OF TREATING TIBIAL SHAFT FRACTURES. HOWEVER, PRECISE CONTROL OF REDUCTION AT THE PROXIMAL AND DISTAL QUARTERS IS DIFFICULT TO ACHIEVE. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE RESULTS OF PLATING (LOCKING COMPRESSION PLATES) USING LOCKING SCREWS AND THE FEASIBILITY OF A MINIMALLY-INVASIVE APPROACH. ALL PATIENTS WITH TIBIAL SHAFT FRACTURE TREATED BY MEANS OF LOCKING PLATES FROM JANUARY 2004 TO OCTOBER 2006. THIRTY-TWO FRACTURES WERE TREATED IN 32 PATIENT¿S AGES BETWEEN 16 AND 90 YEARS OLD. FOLLOW UPS WERE DONE BETWEEN 14 TO 45 MONTHS. FOUR CASES HAD A COMPLICATED COURSE: ONE INFECTION, ONE COMPARTMENT SYNDROME, ONE HARDWARE BREAKAGE AND ONE PSEUDARTHROSIS. WHERE A MINIMALLY-INVASIVE APPROACH CAN BE PERFORMED, IMMEDIATE PAIN-FREE WEIGHT BEARING CAN BE ALLOWED WITHOUT FURTHER DISPLACEMENT AT FOLLOW-UP. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. ONE MEDWATCH FOR NON-UNION AND INFECTION REQUIRING DEVICE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268937 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention