BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3991319 · Received August 8, 2014

    Report

    Report Number
    2520274-2014-12584
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    July 10, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EGLSEDER,W.A., MD (2012). DISTAL HUMERAL FRACTURES: IMPACT OF LATERAL APPROACH AND FRACTURE-SPECIFIC PLATING ON RADIAL NERVE PALSIES. TECHNIQUES IN HAND & UPPER EXTREMITY SURGERY, 16(3), 127-131. THIS REPORT IS FOR AN UNKNOWN HUMERAL PLATE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 JOURNAL ARTICLE, EGLSEDER,W.A., MD (2012). DISTAL HUMERAL FRACTURES: IMPACT OF LATERAL APPROACH AND FRACTURE-SPECIFIC PLATING ON RADIAL NERVE PALSIES. TECHNIQUES IN HAND & UPPER EXTREMITY SURGERY, 16(3), 127-131. THE AUTHORS CONDUCTED A RETROSPECTIVE STUDY OF 73 PATIENTS WHO WERE TREATED FOR SUPRACONDYLAR DISTAL HUMERAL FRACTURES WITH FRACTURE-SPECIFIC PLATING (SYNTHES DISTAL HUMERAL EXTRA-ARTICULAR LOCKING PLATE) AND DEFINITIVE FIXATION THROUGH A LATERAL APPROACH WITH A MEDIAL TRICEPS MOBILIZATION TECHNIQUE BETWEEN 2006 AND 2009. THE AUTHOR DETERMINED THE INCIDENCES OF PREOPERATIVE AND POSTOPERATIVE RADIAL NERVE PALSIES (RNP) TO EVALUATE THE IMPACT OF THE PLATING AND FIXATION TECHNIQUE ON RNP. THE PATIENTS WERE ASSIGNED TO TWO GROUPS: 57 TO THE BLUNT INJURY GROUP (MOTOR VEHICLE COLLISIONS, FALLS, STRUCK PEDESTRIANS, THROWING) AND 16 TO THE GUNSHOT WOUND GROUP. THE INCIDENCE OF KNOWN PREOPERATIVE RNP IN THE BLUNT INJURY GROUP WAS 27 PERCENT; THE INCIDENCE OF KNOWN PREOPERATIVE RNP IN THE GUNSHOT WOUND GROUP WAS 20 PERCENT. THE INCIDENCE OF POSTOPERATIVE RNP FOR THE COMBINED GROUPS OF PATIENTS WHO HAD INTACT RADIAL NERVE FUNCTION PREOPERATIVELY WAS 12 PERCENT. AMONG THE STUDY GROUP OF 73 PATIENTS, ONLY ONE NERVE WAS LACERATED (AND REPAIRED), ONE WAS PARTIALLY LACERATED, AND 11 WERE CONTUSED WITH HEMATOMA NOTED. ULTIMATELY, 15 PATIENTS ACHIEVED COMPLETE RECOVERY, EIGHT EXPERIENCED PARTIAL FUNCTIONAL RECOVERY, AND TWO WERE OF UNKNOWN STATUS. THIS REPORT IS FOR AN UNKNOWN HUMERAL PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). UPDATE 7/29/14: IT WAS REPORTED BY THE AUTHOR ON VERBAL FOLLOW-UP CORRESPONDENCE THAT THE LACERATED AND PARTIALLY LACERATED NERVE WERE A RESULT OF THE ORIGINAL FRACTURE INJURY AND NOT DUE TO THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467175 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention