BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2014-00871

    MDR report key: 3648568 · Received February 26, 2014

    Report

    Report Number
    2520274-2014-00871
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Report Date
    January 31, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    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. THIS REPORT IS ON AN UNKNOWN PLATE, PART AND LOT NUMBERS ARE UNKNOWN. ET.AL: CHANG-WUG OHB, JONG-KEON OHC, JOON-WOO KIM, WOO-KIE MIN, IL-HYUNG PARK, HEE-JUNE KIM QIUGEN WANG. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YUSOF, N., ET AL, (2009). PERCUTANEOUS PLATING IN PAEDIATRIC TIBIAL FRACTURES. INJURY, INT. J. CARE INJURED, 40, 1286¿1291. THE AUTHORS REVIEWED 16 PATIENTS (14 BOYS AND 2 GIRLS) WHOSE TIBIAL FRACTURES WERE TREATED WITH PERCUTANEOUS PLATING TECHNIQUE BETWEEN 2000 AND 2007. MEAN AGE AT OPERATION WAS 10 YEARS 9 MONTHS (RANGE: 6-16 YEARS). SYNTHES DEVICES, PROXIMAL LATERAL TIBIAL LOCKING PLATE, OR LIMITED CONTACT DYNAMIC COMPRESSION PLATE OR PROXIMAL LATERAL TIBIAL LOCKING PLATE WERE USED. MEAN FOLLOW UP WAS ONE YEAR EIGHT MONTHS. A (B)(6) EXPERIENCED SKIN-TISSUE IRRITATION BY PLATE OR SCREWS. THE SYNTHES PLATE WAS NOT SPECIFIED. THE AUTHORS CONCLUDED THAT PERCUTANEOUS PLATING CAN BE SUCCESSFUL WHEN USED FOR TIBIAL FRACTURE CARE IN CHILDREN AND ADOLESCENTS. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117758 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR