BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP PROXIMAL FEMUR PLATE 10 HOLES/283MM-LEFT

    MDR report key: 3070015 · Received April 22, 2013

    Report

    Report Number
    2520274-2013-02052
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K030858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION FROM RECEIVED QUESTIONNAIRE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORTEDLY THE PATIENT WAS RETURNED TO THE O.R IN (B)(6) 2012 (UNSPECIFIED DATE) FOR THE FIRST REVISION SURGERY AND PATIENT WAS REVISED WITH SYNTHES PLATE AND SCREWS. 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

    PATIENT PRESENTED WITH A PROXIMAL FEMUR FRACTURE WAS ORIGINALLY IMPLANTED WITH COMPETITORS NAIL ON AN UNSPECIFIED DATE. REPORTEDLY IN (B)(6) 2012 (UNSPECIFIED DATE). THE PATIENT WAS RETURNED TO THE O.R FOR REMOVAL OF COMPETITORS HARDWARE DUE TO NONUNION. PATIENT WAS REVISED WITH SYNTHES 4.5MM LCP PROXIMAL FEMUR PLATE AND SCREW CONSTRUCT. ON (B)(6) 2013, THE PATIENT WAS RETURNED TO THE O.R FOR A SECOND REVISION SURGERY DUE TO NONUNION. IT WAS NOTED ON AN X-RAY TAKEN ON AN UNSPECIFIED DATE THAT THE PROXIMAL FEMUR PLATE AND SCREW CONSTRUCT CAME APART. REPORTEDLY ON THE PROXIMAL PORTION OF THE PLATE AT THE FIRST THREE SCREW HOLES, THE FIRST AND THIRD SCREWS OF THE PLATE WERE BROKEN AND THE MIDDLE (SECOND HOLE) SCREW WAS BENT. IT WAS REPORTED THE PROXIMAL FEMUR PLATE WAS INTACT. SURGEON REMOVED THE PLATE AND SCREWS AND REVISED THE PATIENT WITH SYNTHES DCS PLATE AND SCREW CONSTRUCT. THIS IS 1 OF 4 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171231 4.5MM LCP PROXIMAL FEMUR PLATE 10 HOLES/283MM-LEFT HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention