BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4694626 · Received April 15, 2015

    Report

    Report Number
    2520274-2015-12821
    Event Type
    Injury
    Date Received
    April 15, 2015
    Report Date
    March 27, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. KAO, F. ET AL (2009). TREATMENT OF DISTAL FEMORAL FRACTURE BY MINIMALLY INVASIVE PERCUTANEOUS PLATE OSTEOSYNTHESIS: COMPARISON BETWEEN THE DYNAMIC CONDYLAR SCREW AND THE LESS INVASIVE STABILIZATION SYSTEM. JOURNAL OF TRAUMA INJURY, INFECTION AND CRITICAL CARE, 67 (4), 719-726. THIS REPORT IS FOR AN UNKNOWN LESS INVASIVE STABILIZATION SYSTEM (LISS SYSTEM) /UNKNOWN QUANTITY/UNKNOWN LOT. REFERS TO LISS SYSTEM: HWC SCREW, FIXATION, BONE. (B)(4). 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

    LITERATURE ARTICLE RECEIVED. THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: KAO, F. ET AL (2009). TREATMENT OF DISTAL FEMORAL FRACTURE BY MINIMALLY INVASIVE PERCUTANEOUS PLATE OSTEOSYNTHESIS: COMPARISON BETWEEN THE DYNAMIC CONDYLAR SCREW AND THE LESS INVASIVE STABILIZATION SYSTEM. JOURNAL OF TRAUMA INJURY, INFECTION AND CRITICAL CARE, 67 (4), 719-726. THIS STUDY INCLUDED 45 SUPRACONDYLAR OR INTERCONDYLAR FEMORAL FRACTURES THAT WERE TREATED WITH MINIMALLY INVASIVE PERCUTANEOUS PLATING WITH THE DYNAMIC CONDYLAR SCREW (DCS), CONSISTING OF THE DCS PLATE AND SCREWS, OR THE LESS INVASIVE STABILIZATION SYSTEM (LISS). LISS SYSTEM CONSISTS OF A PLATE AND AT LEAST FOUR BICORTICAL LOCKING SCREWS AND AT LEAST FOUR UNICORTICAL LOCKING SCREWS. THERE WERE 26 PATIENTS WITH 26 FRACTURES IN THE DCS GROUP AND 19 PATIENTS WITH 19 FRACTURES IN THE LISS GROUP. THERE WAS A CASE OF NONUNION AND IMPLANT LOOSENING. AN INFECTION AT THE NONUNION SITE REPORTED, REQUIRING DEBRIDEMENT AND SUBSEQUENT BONE GRAFTING. THIS IS REPORT 1 OF 8 FOR COM-(B)(4). THIS REPORT IS FOR AN UNKNOWN LESS INVASIVE STABILIZATION SYSTEM (LISS SYSTEM). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250811 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention