BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3894721 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-12043
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. METAPHYSEAL LOCKING PLATE AS A DEFINITIVE EXTERNAL FIXATOR FOR TREATING OPEN TIBIAL FRACTURES - CLINICAL OUTCOME AND FINITE ELEMENT STUDY. CHING-HOU, M., CHIN-HSIEN, W., YUAN-KUN, T., TING-SHENG, L. (2013) ELSEVIER: INJURY, INT. J. CARE INJURED 44, 1097-1101. THIS REPORT IS FOR AN UNKNOWN PLATE /UNKNOWN QUANTITY/UNKNOWN LOT. 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. METAPHYSEAL LOCKING PLATE AS A DEFINITIVE EXTERNAL FIXATOR FOR TREATING OPEN TIBIAL FRACTURES - CLINICAL OUTCOME AND FINITE ELEMENT STUDY. CHING-HOU, M., CHIN-HSIEN, W., YUAN-KUN, T., TING-SHENG, L. (2013) ELSEVIER: INJURY, INT. J. CARE INJURED 44, 1097-1101. THIS IS A RETROSPECTIVE STUDY A TOTAL OF 68 PATIENTS WITH OPEN TIBIAL FRACTURES BETWEEN JANUARY 2006 AND DECEMBER 2010. THE GEOMETRY OF THE BONE PLATE WAS DEVELOPED USING COMPUTER-AIDED DESIGN (CAD) SOFTWARE BASED ON THE LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE (SYNTHES, INC., (B)(4)). DURING THIS PERIOD, THERE WERE THREE PATIENTS; ONE WITH A DELAYED UNION OF THE DISTAL FRACTURE WITH BROKEN SCREWS AND TWO PATIENTS WITH MINOR SCREW TRACT INFECTIONS WHICH RESOLVED AFTER ORAL ANTIBIOTIC THERAPY. ALL THE FRACTURES UNITED AND THE MEAN BONE HEALING TIME WAS 37.5 WEEKS (RANGE, 20¿52 WEEKS). ALL PATIENTS HAD EXCELLENT OR GOOD FUNCTIONAL RESULTS AND WERE WALKING FREELY AT THE FINAL FOLLOW-UP. THIS IS REPORT 3 OF 4 FOR (B)(4). THIS REPORT REFERS TO AN UNKNOWN LISS PLATE AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371853 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention