BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2014-00788

    MDR report key: 3643133 · Received February 24, 2014

    Report

    Report Number
    2520274-2014-00788
    Event Type
    Injury
    Date Received
    February 24, 2014
    Report Date
    January 29, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL DEVICE INFO: THIS REPORT IS ON UNKNOWN SCREWS, PART AND LOT NUMBERS ARE UNKNOWN. DATE OF EVENT: 2012. PMA/510 (K): WITHOUT A PART NUMBER THE 510K NUMBER CANNOT BE PROVIDED. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: RELIABILITY OF LOCKED PLATING IN TIBIAL PLATEAU FRACTURES WITH A MEDIAL COMPONENT.: ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH (2012) 98, 173-179. (2012). M. EHLINGER, M. RAHME, B. K. MOOR, A. DIMARCO, D. BRINKERT, P. ADAM, F. BONNOMET. THIS ARTICLE DOES MENTION SYNTHES PRODUCT. STUDY HYPOTHESIZED THAT COMPLEX ARTICULAR FRACTURES OF THE TIBIAL PLATEAU HAVING A MEDIAL OR POSTEROMEDIAL FRAGMENT WOULD BE EFFECTIVELY STABILIZED USING A SINGLE LATERAL ANATOMICALLY CONTOURED LOCKED PLATE. (SYNTHES LCP PLATE WAS USED). FROM (B)(6) 2005 TO (B)(6) 2008, 20 PATIENTS, TEN WOMEN AND TEN MEN, MEAN AGE 47 YEARS WERE TREATED WITH A LCP PLATE FOR TIBIAL PLATEAU FRACTURES HAVING A MEDIAL COMPONENT. AUTHORS COMPARED OTHER STUDIES, OF PLATING, AND HYPOTHESIZED THAT COMPLEX ARTICULAR FRACTURES OF THE TIBIAL PLATEAU HAVING A MEDIAL OR POSTEROMEDIAL FRAGMENT WOULD BE EFFECTIVELY STABILIZED USING A SINGLE LATERAL ANATOMICALLY CONTOURED LOCKED PLATE. CONCLUSION: HEALING WAS ACHIEVED IN ALL 20 PATIENTS AFTER A MEAN OF 10 WEEKS. A SINGLE LATERAL LOCKING PLATE ENSURED GOOD OUTCOMES IN PATIENTS WITH PROXIMAL ARTICULAR FRACTURES OF THE TIBIA HAVING A MEDIAL COMPONENT. IMAGING STUDY RESULTS WERE STABLE OVER TIME AND THE SHORT TERM CLINICAL OUTCOMES WERE SATISFACTORY. EVENTS: SEVEN UNIDENTIFIED PATIENTS UNDERWENT HARDWARE REMOVAL AFTER A MEAN OF 18 MONTHS. HARDWARE REMOVAL WAS FOLLOWED BY INFECTION. THIS REPORT IS ON UNKNOWN SCREWS, QUANTITY IS UNKNOWN. THIS IS 2 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111962 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention