BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_KIE_PRODUCT

    MDR report key: 4204130 · Received October 27, 2014

    Report

    Report Number
    0009610622-2014-00597
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    April 11, 2014
    Report Date
    September 16, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS NOT CONFIRMED. THE CONDYLAR SCREW WAS CLASSIFIED AS PRIMARY PRODUCT BY THE EVENT DESCRIPTION. AN INVESTIGATION AND A REVIEW OF THE DHR WERE NOT POSSIBLE BECAUSE THE IMPLANT AND THE LOT CODE WERE NOT AVAILABLE. FURTHERMORE NO ADDITIONAL INFORMATION LIKE X-RAYS OR SURGERY RECORDS WAS PROVIDED. THE ROOT CAUSE COULD NOT BE DETERMINED. POTENTIAL CAUSES: WRONG IMPLANT SIZE, WRONG IMPLANT POSITIONING, WRONG IMPLANT COMBINATION, PATIENT RELATED (PAIN SENSITIVE, OVERLOADING THE IMPLANTS). THE IFU INCLUDES SEVERAL WARNINGS THAT THE IMPLANT SIZE, POSITION AND COMBINATION MUST BE CHECKED PRE- AND INTRA-OPERATIVELY; FURTHERMORE PATIENT RELATED EFFECTS ARE ALSO LISTED. THE OPERATIVE TECHNIQUE FOR THE T2 SCN SYSTEM DESCRIBES THE CORRECT HANDLING AND IMPLANTATION OF THE IMPLANTS IN DETAIL. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO PREVIOUS OR ACTUAL ACTIONS ARE IN PLACE. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THE SURGERY WITH T2 SCN. AFTER SURGERY, THE PATIENT FELT THE PAIN IN THE INSERTION PART OF THE CONDYLAR SCREW. THEREFORE THE SURGEON PERFORMED THE OPERATION WHICH REMOVES THE CONDYLAR SCREW. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681917 UNKNOWN_KIE_PRODUCT IMPLANT HSB STRYKER TRAUMA KIEL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention