BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIRE/PIN

    MDR report key: 2827208 · Received November 9, 2012

    Report

    Report Number
    2520274-2012-03034
    Event Type
    Injury
    Date Received
    November 9, 2012
    Report Date
    October 12, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    DZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    THE CONSULTANT REPORTS REGARDING AN INCIDENT WHEREBY, POSTOPERATIVELY, A PATIENT IMPLANTED WITH A MANDIBLE MULTI-VECTOR DISTRACTOR PULLED A K WIRE PIN(S), UNKNOWN HOW MANY, OUT OF THE MANDIBLE WHEN THE TOWEL THE PATIENT WAS USING ON THE FACIAL AREA, SNAGGED THE DEVICE. THERE WAS NO INJURY TO THE PATIENT NOTED HOWEVER, THE PIN(S) DID NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRE/PIN DZK SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DISTRACTOR, WIRE/PIN