BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM KIRSCHNER WIRE W/CALIB W/15MM THRD-TROCAR POINT-150MM

    MDR report key: 3240908 · Received July 22, 2013

    Report

    Report Number
    2520274-2013-04550
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 28, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    PMA / PMN Number
    K981362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EVENT OCCURRED DURING A MANDIBULAR OSTEOTOMY. THE DISTRACTOR DID NOT FULLY ADVANCE ON ONE SIDE OF THE MANDIBLE AND THE SURGEON FELT THE DISTRACTOR WAS NOT HOLDING ITS POSITION. THE DISTRACTOR DISTRACTED APPROPRIATELY BUT WOULD GO BACKWARDS AND WOULD NOT ADVANCE. THE SURGEON PERFORMED A REVISION SURGERY ON A LATER UNKNOWN DATE TO RE-OSTEOTOMIZE THE MANDIBLE AND BEGIN DISTRACTING AGAIN. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340425 2.0MM KIRSCHNER WIRE W/CALIB W/15MM THRD-TROCAR POINT-150MM MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention