BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM VA-LCP OLECRANON PL 4H/RT/116MM

    MDR report key: 3202462 · Received July 2, 2013

    Report

    Report Number
    3003506883-2013-00291
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K120070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REVIEW OF THE RESPECTIVE RAW MATERIAL AND FINISHED PRODUCT DHR FILES FOUND NO IRREGULARITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS CONDITION. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH 2.7MM/3.5MM A VARIABLE ANGLE LOCKING COMPRESSION (VA-LCP) OLECRANON PLATE AND SCREW CONSTRUCT ON (B)(6) 2013. CLINICAL FINDINGS NOTED THE PATIENT HAD A DELAYED HEALING. THE PATIENT PRESENTED WITH NON-UNION. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013, FOR REMOVAL OF HARDWARE REPORTEDLY DUE TO FAILURE OF FIXATION. THE HARDWARE WAS REMOVED WITHOUT COMPLICATION. REPORTEDLY THERE IS NO ANTICIPATED TREATMENT AT THIS TIME. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302091 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/RT/116MM HRS SYNTHES ELMIRA 7009514

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention