BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3790736 · Received May 5, 2014

    Report

    Report Number
    2520274-2014-11089
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 22, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT FOR DIAGNOSIS. EIDELMAN, M., KEREN, Y., NORMAN, D., (2012), CORRECTION OF DISTAL FEMORAL VALGUS DEFORMITIES IN ADOLESCENTS AND YOUNG ADULTS USING MINIMALLY INVASIVE FIXATOR-ASSISTED LOCKING PLATING (FALP)., JOURNAL OF PEDIATRIC ORTHOPAEDICS, 21, 558-562. THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATE. 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: EIDELMAN, M., KEREN, Y., NORMAN, D., (2012), CORRECTION OF DISTAL FEMORAL VALGUS DEFORMITIES IN ADOLESCENTS AND YOUNG ADULTS USING MINIMALLY INVASIVE FIXATOR-ASSISTED LOCKING PLATING (FALP)., JOURNAL OF PEDIATRIC ORTHOPAEDICS, 21, 558-562. IN THIS STUDY, THE AUTHORS ANALYZED THEIR EXPERIENCE WITH CORRECTION OF DISTAL FEMORAL VALGUS DEFORMITY. SEVERAL SURGICAL OPTIONS EXIST FOR THE CORRECTION OF VALGUS DEFORMITIES OF THE DISTAL FEMUR: GRADUAL CORRECTION USING EXTERNAL FIXATION, INTERNAL FIXATION BY DIFFERENT PLATES AND STAPLES, AND INTRAMEDULLARY NAILING. LOCKING COMPRESSION PLATE TECHNOLOGY ALLOWS THE SURGEON TO APPLY THE PLATE AFTER TRANSLATION OF THE OSTEOTOMY, WHILE PART OF THE PLATE ABOVE THE OSTEOTOMY LEVEL DOES NOT ATTACH TO THE FEMUR DIRECTLY. INSERTION OF A LOCKING COMPRESSION PLATE CAN BE ACHIEVED WITH MINIMAL EXPOSURE THROUGH TWO SMALL SKIN INCISIONS BY A SUBVASTUS APPROACH. TEMPORARY EXTERNAL FIXATION ALLOWS PRECISE CORRECTION OF THE DEFORMITY AND CAN BE REMOVED AT THE END OF THE OPERATION. OVER A TWO PERIOD SIX PATIENTS WERE OPERATED ON WITH DISTAL FEMORAL VALGUS DEFORMITIES. THERE WERE FOUR GIRLS AND TWO BOYS BETWEEN THE AGES OF 15 AND 18 YEARS. THERE WERE NO MAJOR COMPLICATIONS TO REPORT EXCEPT FOR ONE PATIENT COMPLAINED OF A MILD DISCOMFORT ON THE DISTAL LATERAL SIDE OF THE THIGH AROUND THE PLATE. THE SYMPTOMS DISAPPEARED AFTER PLATE REMOVAL. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. MEDWATCH 1 OF 2 FOR PLATE DISCOMFORT AND REMOVAL, PLATE. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266671 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention