BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3813516 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11295
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 25, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS OF THE DISTAL FIBULA WITH THE LOCKING COMPRESSION PLATE: FIRST EXPERIENCE OF 20 CASES.¿ THIS REPORT IS FOR UNKNOWN LCP SCREWS/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, "MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS OF THE DISTAL FIBULA WITH THE LOCKING COMPRESSION PLATE: FIRST EXPERIENCE OF 20 CASES.¿ HESS, F. AND SOMMER, C. (2011) JOURNAL OF ORTHOPAEDIC TRAUMA, 25:110-115. A COHORT STUDY WAS PERFORMED DURING THE STUDY PERIOD OF MARCH 2001 TO APRIL 2006, 701 ADULT PATIENTS WERE ADMITTED TO A HOSPITAL WITH UNSTABLE DISTAL LOWER LEG, ANKLE, OR PILON FRACTURES REQUIRING INTERNAL STABILIZATION OF ONE OR BOTH BONES. OF THESE, 255 PATIENTS REQUIRED PLATE FIXATION OF THE FIBULA, BUT ONLY 20 FULFILLED THE INCLUSION CRITERIA FOR A MIPO TECHNIQUE OF THE FIBULA. THE STUDY INCLUDED 20 FRACTURES IN 20 PATIENTS. THERE WERE 10 MALES AND 10 FEMALES WITH A MEAN AGE OF 53.7 6 28.2 YEARS (RANGE, 15¿84 YEARS). THE LCP METAPHYSEAL PLATE 3.5 (SYNTHES, SOLOTHURN, SWITZERLAND) WITH A LOW-PROFILE FLATTENED DISTAL END WAS USED AS THE MAIN IMPLANT, ALTHOUGH ALTERNATIVELY IN A FEW CASES, A LCP ONE THIRD TUBULAR PLATE WAS APPLIED. SEVENTEEN FRACTURES HEALED WITHOUT COMPLICATION IN AN AVERAGE OF 9 WEEKS. ONE PATIENT (ACTIVE MOUNTAIN FARMER) DEVELOPED A DELAYED UNION WITH SECONDARY IMPLANT FAILURE (SCREW LOOSENING) AS A RESULT OF AVASCULARITY AND EARLY UNCONTROLLED FULL WEIGHT BEARING. THE NONUNION HEALED WITHOUT FURTHER COMPLICATIONS AFTER A SINGLE FORMAL OPEN REVISION USING PLATES AND BONE GRAFT. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN LCP SCREWS. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290534 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention