BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2954874 · Received February 11, 2013

    Report

    Report Number
    2520274-2013-00844
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    June 9, 2012
    Report Date
    January 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT DATE REPORTED WAS (B)(6) 2010. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED A PLATE WAS IMPLANTED IN (B)(6) 2010. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2011 FOR REMOVAL. DURING THE REMOVAL PROCEDURE IT WAS NOTED THAT 2 SCREWS COULD NOT BE REMOVED FROM THE PLATE. THE PROCEDURE WAS STOPPED AT THIS POINT. ON (B)(6) 2012 THE PATIENT WAS AGAIN RETURNED TO THE O.R . THE SCREW HEADS WERE DRILLED OUT AND THE PLATE WAS REMOVED BIT BY BIT. PART OF THE SCREWS REMAINED IN THE PATIENT. THE CONSEQUENCE OF THIS OCCURRENCE WAS THE NECESSITY TO TAKE THE PATIENT ONCE AGAIN WITH GENERAL ANESTHETIC TO REMOVE THE PLATE AND THE REMAINING SCREWS. THIS REPORT IS #2 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58403 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention