BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCALIBER BONE SCREW STERILE L 260/60MM THREAD

    MDR report key: 2894263 · Received December 27, 2012

    Report

    Report Number
    9680825-2012-00043
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    September 21, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THIS SPECIFIC LOT BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2010, WAS COMPRISED OF 100 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST BREAKAGE NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL INVESTIGATION: THE TECHNICAL INVESTIGATION ON THE RETURNED BROKEN SCREW IS CURRENTLY ONGOING. ORTHOFIX (B)(4) HAS REQUESTED TO THE DISTRIBUTOR INVOLVED PT'S DETAILS INCLUDING AN UPDATE ON THE CURRENT HEALTH CONDITION AND COPY OF THE PRE AND POST OPERATIVE X-RAYS. UNFORTUNATELY, THIS INFORMATION HAS NOT YET MADE AVAILABLE. AS SOON AS FURTHER INFORMATION AND/OR THE RESULTS OF THE TECHNICAL INVESTIGATION WILL BE AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) UNIVERSITY HOSPITAL. SURGEON'S NAME: DR (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2012. PT TREATED FOR ANGULAR CORRECTION OF THE PROXIMAL TIBIA. ON (B)(6) 2012, THE SURGEON REMOVED TWO BONE SCREWS AS PLANNED IN THE SURGEON OFFICE AND DECIDED TO REMOVE THE OTHER TWO BONE SCREWS ONE WEEK LATER. AS THE PT FELT PAIN, THE SURGEON PERFORMED AN X-RAY WHICH REVEALED THAT A BONE SCREW WAS BROKEN. FOR THIS REASON, A NEW SURGERY WAS REQUIRED TO REMOVE THE BROKEN SCREW. THIS SURGERY WAS MADE ON (B)(6), 2012. THE BONE SCREW BREAKAGE OCCURRED DURING THE WEEK (B)(6) 2012. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCALIBER BONE SCREW STERILE L 260/60MM THREAD XCALIBER BONE SCREW STERILE L 260/60MM THREAD JDW ORTHOFIX SRL 99-912660 10225381

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention NO INFORMATION HAVE BEEN MADE AVAILABLE.