BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/14MM

    MDR report key: 2831920 · Received November 14, 2012

    Report

    Report Number
    2520274-2012-03144
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 17, 2012
    Product Code
    HWC
    PMA / PMN Number
    K093772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL IMPLANT DATE UNKNOWN. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A PROCEDURE TO EXPLANT A STERNAL PLATE AND SCREWS FROM A PATIENT. THE INITIAL IMPLANT WAS PERFORMED ON AN UNKNOWN DATE. POST-OPERATIVELY, THE PATIENT RETURNED TO SURGEON WITH FLU-LIKE SYMPTOMS AND SEVERE COUGHING. EXAMINATION REVEALED THAT THE STERNAL PLATE HAD BECOME DISLODGED FROM THE STERNUM, AND THERE WAS A FRACTURE IN THE STERNUM, LATERAL TO THE PLATE. THE SURGEON RETURNED THE PATIENT TO THE OR, REMOVED ONE PLATE AND SIX SCREWS AND REVISED THE PATIENT TO NEW STERNAL FIXATION HARDWARE. THE SURGEON NOTED THAT THE DISLODGING OF THE IMPLANT AND THE STERNUM FRACTURE LATERAL TO THE PLATE WERE THE RESULT OF THE PATIENT COUGHING EXCESSIVELY AND AGGRESSIVELY. THE PATIENT IS REPORTEDLY RECOVERING WELL. THIS IS REPORT # 7 OF 7 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/14MM STERNAL LOCKING SCREW HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention