BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCALIBER META-DIAPHYSEAL KIT STERILE

    MDR report key: 2742883 · Received September 9, 2012

    Report

    Report Number
    9680825-2012-00034
    Event Type
    Malfunction
    Date Received
    September 9, 2012
    Date of Event
    July 2, 2012
    Report Date
    September 5, 2012
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL 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, MFG IN 2011, WAS COMPRISED OF (B)(4) DEVICES. (B)(4). ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER SIMILAR FAILURES HAVE BEEN REPORTED FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL 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 AND THE DEVICE AVAILABILITY FOR THE TECHNICAL INVESTIGATION. UNFORTUNATELY, THIS INFO HAS NOT YET BEEN MADE AVAILABLE. AS SOON AS FURTHER INFO AND/OR THE RESULTS OF THE TECHNICAL INVESTIGATION WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A F/U REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFO PROVIDED BY THE DISTRIBUTOR INDICATES: DURING THE OPERATION, WHEN WE TRIED TO FIX THE CLAMP SCREW OF THE FIXATOR CODE (B)(4), THE MAIN PART OF THE DEVICE SUDDENLY CRACKED WITHOUT BEING SWIVELLED REPEATEDLY. NO OTHER INFO HAS BEEN MADE AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCALIBER META-DIAPHYSEAL KIT STERILE XCALIBER META-DIAPHYSEAL KIT STERILE JDW ORTHOFIX SRL 99-91000 V1228388

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NO INFO HAS BEEN MADE AVAILABLE.