BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM TI VA-LCP LAT DSTLHUMERUS PL 1H/LT/69MM-SHORT

    MDR report key: 2882489 · Received December 20, 2012

    Report

    Report Number
    3003506883-2012-00405
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    July 7, 2012
    Report Date
    November 22, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A SURGEON IN (B)(6) REPORTED: SURGEON WAS PARTICIPANT IN MPE EVALUATION: THE DORSO LATERAL PLATE WAS NOT AVAILABLE TO USE DURING THE PROCEDURE; SURGEON SELECTED A VA LCP LATERAL DISTAL PLATE, CONTOURED IT, AND APPLIED FROM THE DORSO LATERAL, DATE UNKNOWN. PATIENT HAD DAILY PHYSIOTHERAPY; BETWEEN PHYSIOTHERAPIES FIXATION WITH ORTHESIS. THREE WEEKS AFTER PROCEDURE THERE WAS A FAILURE OF THE OS, NONUNION. PATIENT HAD HARDWARE REMOVED, LATERAL PLATE, ALONG WITH A SYNTHES VA LCP DHP PLATE. THE IMPLANT DATE OF THE DHP PLATE IS ALSO UNKNOWN. PATIENT WAS REVISED TO FIXATION WITH K WIRES. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.7MM/3.5MM TI VA-LCP LAT DSTLHUMERUS PL 1H/LT/69MM-SHORT VA-LCP LAT DSTLHUMERUS PLATE HRS SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention