BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3985256 · Received August 6, 2014

    Report

    Report Number
    2520274-2014-12598
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. GUIDED GROWTH WITH A NONCANNULATED SCREW-PLATE SYSTEM FOR ANGULAR DEFORMITY OF THE KNEE: A PRELIMINARY REPORT. HYUN-JOO LEE, CHANG-WUG OH, KWANG-SOON SONG, HEE-SOO KYUNG, WOO-KIE MIN, BYUNG-CHUL PARK; 2012 JOURNAL OF PEDIATRIC ORTHPEDAEDICS B; VOL 21 NO 4. THIS REPORT IS FOR AN UNKNOWN (PART/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 SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE. GUIDED GROWTH WITH A NONCANNULATED SCREW-PLATE SYSTEM FOR ANGULAR DEFORMITY OF THE KNEE: A PRELIMINARY REPORT. HYUN-JOO LEE, CHANG-WUG OH, KWANG-SOON SONG, HEE-SOO KYUNG, WOO-KIE MIN, BYUNG-CHUL PARK; 2012 JOURNAL OF PEDIATRIC ORTHPEDAEDICS B; VOL 21 NO 4. THIS IS A RETROSPECTIVE REVIEW OF 27 ANGULAR DEFORMITIES OF THE KNEE IN 16 PATIENTS (11 BOYS AND FIVE GIRLS) TREATED BY THE GUIDED GROWTH TECHNIQUE USING A 3.5-MM RECONSTRUCTION PLATE AND TWO 3.5-MM CORTICAL SCREWS (SYNTHES, (B)(4)). MOVEMENT OF THE SCREW HEAD AT THE INTERFACE OF PLATE AND SCREW WAS SEEN IN ALL, EXCEPT ONE CASE. TWO CASES WERE IDENTIFIED AS A 7 YEAR-OLD GIRL AND A 9 YEAR-OLD BOY. THE SCREW HEAD WAS NOT DAMAGED OR BROKEN IN ANY CASES. THIS REPORT IS 1 OF 6 FOR (B)(4). THIS REPORT REFERS TO 7 YO GIRL - PLATE DEVICE INTERACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460081 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR