BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL LATERAL FEMUR PLATE TS AXSOS FOR LEFT FEMUR 16 HOLE / L343MM

    MDR report key: 3770819 · Received April 24, 2014

    Report

    Report Number
    0008031020-2014-00197
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    STRYKER GMBH (MDR)
    Product Code
    HRS
    PMA / PMN Number
    K061012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE , IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT OF THE PLATE BREAKAGE COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND IT WAS NOT POSSIBLE TO ASCERTAIN FROM THE PRE-OPERATIVE X-RAYS PROVIDED. BASED ON THE CURRENTLY AVAILABLE INFORMATION, THERE WAS NO FAILURE OF THE DEVICE. REGARDING THE PRE-OPERATIVE X-RAYS PROVIDED, THERE WAS AN EVIDENT NON-UNION OF THE BONE, JUST LIKE RELATED IN THE EVENT DESCRIPTION. THE PLATE DIDN¿T SHOW ANY SIGNS OF BREAKAGE, ALTHOUGH IT WAS ALSO OBSERVED A SLIGHT BEND IN THE PLATE. HOWEVER, WITHOUT ANY FURTHER INFORMATION, IT IS NOT POSSIBLE TO CONFIRM IF THE PLATE WAS BEND DURING THE SURGERY, IN ORDER TO BETTER FIT THE BONE SHAPE OF THE PATIENT, OR IF IT WAS A RESULT OF THE NON-UNION OF THE BONE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED BECAUSE THE PLATE BROKE DUE TO NON UNION OF THE BONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED BECAUSE THE PLATE BROKE DUE TO NON UNION OF THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249220 DISTAL LATERAL FEMUR PLATE TS AXSOS FOR LEFT FEMUR 16 HOLE / L343MM PLATE, FIXATION, BONE HRS STRYKER GMBH (MDR) X34373

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention