BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FXATION, BONE

    MDR report key: 3930940 · Received July 13, 2014

    Report

    Report Number
    2520274-2014-12245
    Event Type
    Injury
    Date Received
    July 13, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LUI, T.H. (2011) OPENING WEDGE LOW TIBIAL OSTEOTOMY: A MINIMALLY INVASIVE APPROACH. FOOT AND ANKLE SURGERY 17: 1-7. THIS REPORT IS FOR ONE UNKNOWN LCP METAPHYSEAL PLATE/LOT UNKNOWN. 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: OPENING WEDGE LOW TIBIAL OSTEOTOMY: A MINIMALLY INVASIVE APPROACH. LUI, T.H. (2011) OPENING WEDGE LOW TIBIAL OSTEOTOMY: A MINIMALLY INVASIVE APPROACH. FOOT AND ANKLE SURGERY 17: 1-7. (B)(6) YEAR OLD FEMALE PATIENT WITH MULTIPLE EXOSTOSIS UNDERWENT PERCUTANEOUS VARUS OPENING WEDGE OSTEOTOMY IN AUGUST 2009 USING THE SYNTHES LCP METAPHYSEAL PLATE. POSTOPERATIVELY, IT WAS COMPLICATED WITH WOUND BREAKDOWN OF THE OSTEOTOMY SITE. WOUND SWAB DID NOT YIELD ANY ORGANISM. SHE WAS TREATED WITH DAILY DRESSING AND THE WOUND HEALED UP. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN LCP METAPHYSEAL PLATE. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409014 PLATE, FXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention