BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_FRO_PRODUCT

    MDR report key: 3250385 · Received July 26, 2013

    Report

    Report Number
    0008010177-2013-00173
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 3, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED SINCE A METAL FRAGMENT WAS SENT BACK FOR INVESTIGATION. BASED ON THE AVAILABLE INFORMATION, IT WAS NOT POSSIBLE TO DETERMINE THE DEFINITIVE ORIGIN OF THE METAL FRAGMENT. THE MACROSCOPIC AND MICROSCOPIC INVESTIGATION RESULTS SHOWED THAT MOST LIKELY THE THREAD OF THE LOCKING SCREW, CROSS-PIN WAS PEELED OFF AND DETACHED IN A FILAMENTOUS FORM DUE TO COLLISION AND FRICTION WITH A HARD OBJECT LIKE PLATE (NO BONE). THEREFORE, THE ROOT CAUSE FOR THE REPORTED EVENT CAN BE ATTRIBUTED TO A USER RELATED ISSUE. NO INDICATIONS WERE FOUND FOR ANY DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 1

    AFTER THE EXTRACTION OF VARIAX DR, THE METAL PIECE WAS FOUND FROM THE PATIENT BODY.

    Description of Event or Problem · 1

    AFTER THE EXTRACTION OF VARIAX DR, THE METAL PIECE WAS FOUND FROM THE PATIENT BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350979 UNKNOWN_FRO_PRODUCT IMPLANT HRS STRYKER OSTEOSYNTHESIS-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1