BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_TRAUMA_AND_EXTREMITY_PRODUCT

    MDR report key: 4204079 · Received October 27, 2014

    Report

    Report Number
    0008031020-2014-00514
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    June 28, 2014
    Report Date
    September 12, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. BASED ON THE EVENT DESCRIPTION, MOST LIKELY THE REPORTED PROBLEM IS RELATED TO AN EXCESSIVE MECHANICAL OVERLOAD ON THE IMPLANT SIDE APPLIED DUE TO THE REPORTED IMPACT. STRYKER ELBOW PLATE CONFIGURATIONS ARE DESIGNED IN ORDER TO PROVIDE SUFFICIENT MECHANICAL STABILITY TO ALLOW EARLY POSTOPERATIVE REHABILITATION WITH A REDUCED LOADING PROTOCOL. FURTHERMORE, SPECIFIC POST- OPERATIVE PRECAUTIONS SHOULD BE TAKEN BY THE PATIENT. THE DEVICE CANNOT AND DOES NOT REPLICATE A NORMAL HEALTHY BONE, AND IT CAN BREAK OR BECOME DAMAGED AS A RESULT OF STRENUOUS ACTIVITY, MAL-UNION, NON-UNION OR TRAUMA, AS THE ONE REPORTED (AS PER IFUS). THE FOLLOWING STATEMENTS ARE ADDRESSING THE REPORTED EVENT: IFUS FOR NON-ACTIVE IMPLANT, V15013/J XX/11 REVIEW. VARIAX ELBOW PLATING SYSTEM OPERATIVE TECHNIQUE: 982335 REV. 2. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    AFTER VARIAX ELBOW SURGERY, PATIENT FELL DOWN AND RE-FRACTURE HAS OCCURRED. REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681555 UNKNOWN_TRAUMA_AND_EXTREMITY_PRODUCT IMPLANT HTY STRYKER TRAUMA SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention