BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-05065

    MDR report key: 3302685 · Received August 22, 2013

    Report

    Report Number
    2520274-2013-05065
    Event Type
    Injury
    Date Received
    August 22, 2013
    Date of Event
    November 13, 2012
    Report Date
    July 31, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: IN-DEPTH ORAL PRESENTATIONS, ORAL COMMUNICATIONS AND RESIDENTS ORAL COMMUNICATIONS. JOURNAL ORTHOPAED TRAUMATOL (SUPPL 1):S91-S123). NOVEMBER 13 2012. IN DEPTH ORAL PRESENTATION: NEUROLOGICAL COMPLICATIONS OF PAEDIATRIC HUMERAL SUPRACONDYLAR FRACTURES: RETROSPECTIVE ANALYSIS OF 5,119 CASES TREATED AT A.O.R.N. S. ANNUNZIATA, P. DI GIACOMO, G. FEDERICO, A. SORRENTINO OF NAPLES, B. DI MAIO, M. RIZZO, L. CARBONE, N. DE SANCTIS, AND P. GUIDA. SYNTHES IS NOT MENTIONED IN THIS ARTICLE, IT IS UNKNOWN IF THIS IS A SYNTHES DEVICE. THIS PRESENTATION IS A STUDY TO SEE IF PREDICTIVE FACTORS OF COMPLICATIONS EXIST IN HUMERAL SUPRACONDYLAR FRACTURES OF THE ELBOW. TIME FRAME: 1996 TO 2009 FRACTURES TREATED WITH REDUCTION AND PERCUTANEOUS TRANS LATERAL CONDYLAR FIXATION WITH 2 OR 3 KIRSCHNER WIRES. IN 358 CASES (7%) A NEUROLOGICAL COMPLICATION WAS DIAGNOSED: 136 CASES, ANTERIOR INTEROSSEOUS NERVE INVOLVED. 97 CASES: RADIAL NERVE INVOLVED. 71 PATIENTS: MEDIAN NERVE INVOLVED. 54 PATIENTS: ULNAR NERVE INVOLVED. NERVE FUNCTION IS RECOVERED WITHIN 6 MONTHS FOR ANTERIOR INTEROSSEOUS NERVE, 4 TO 5 MONTHS FOR RADIAL NERVE, 6 MONTHS FOR MEDIAN NERVE, AND 6 TO 7 MONTHS FOR ULNAR NERVE. IN CASE OF PERSISTENCE OF SIGNIFICANT SYMPTOMS AT 6 MONTHS AFTER TRAUMA, SURGICAL EXPLORATION IS INDICATED. THIS COMPLAINT IS ON THE GUIDE WIRE. THE QUANTITY FOR THE GUIDE WIRES IS UNKNOWN. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407477 LRN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention