BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADV STRAIGHT CLAMP

    MDR report key: 3457802 · Received October 10, 2013

    Report

    Report Number
    9680825-2013-00024
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Date of Event
    August 23, 2013
    Report Date
    October 10, 2013
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K955848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: THE CLAMP SCREW THAT BROKE HAS NOT BEEN MADE AVAILABLE FOR THE INVESTIGATION. UNFORTUNATELY ALSO THE CODE AND THE LOT NUMBER OF THE CLAMP SCREW HAVE NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. ORTHOFIX SRL IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICE CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. MANUFACTURER COMMENTS: ORTHOFIX SRL HAS REQUESTED FURTHER INFORMATION ON THE EVENT SUCH AS INFORMATION ON CODE AND LOT OF THE CLAMP SCREW THAT BROKE, DEVICE AVAILABILITY FOR THE TECHNICAL EVALUATION, PATIENT DIAGNOSIS, COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE PRE AND POST-OPERATIVE X-RAYS TO PERFORM THE MEDICAL EVALUATION. UNFORTUNATELY, THIS INFORMATION HAS NOT YET MADE AVAILABLE. AS SOON AS FURTHER INFORMATION WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF SURGERY: (B)(6) 2013. THE DOCTOR TIGHTENED CLAMP SCREW IN CLINIC AND THE CLAMP SCREW BROKE OFF. CLAMP WAS REPLACED ON (B)(6) 2013. NO ADVERSE EFFECTS TO PATIENT. AN ADDITIONAL SURGERY WAS REQUIRED FOLLOWING DEVICE FAILURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520262 ADV STRAIGHT CLAMP ADV STRAIGHT CLAMP JDW ORTHOFIX SRL 53530 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR