BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM MANDIBLE ELEVATED MESH FOOT B-TYPE 5.5MM OFFSET

    MDR report key: 3060978 · Received April 16, 2013

    Report

    Report Number
    2520274-2013-01960
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    February 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    PMA / PMN Number
    K060138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. DATE OF EVENT WAS REPORTED AS MID 2012.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH DUAL MANDIBLE DISTRACTORS ON (B)(6) 2012. SURGEON REPORTED THAT THE FOOT PLATES ON THE DISTRACTORS BROKE IN MID-2012. PATIENT RETURNED TO THE O.R. FOR REMOVAL OF HARDWARE ON (B)(6) 2012. AT THIS TIME, PATIENT WAS NOT REVISED WITH ANY OTHER HARDWARE. PATIENT RETURNED TO THE O.R. AGAIN ON (B)(6) 2013 FOR ANOTHER REVISION SURGERY, AT WHICH TIME PATIENT WAS IMPLANTED WITH ADDITIONAL HARDWARE. IT IS REPORTED THAT PATIENT HAS HAD TEN OR MORE PREVIOUS SURGERIES FOR MANDIBLE DISTRACTION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163573 1.5MM MANDIBLE ELEVATED MESH FOOT B-TYPE 5.5MM OFFSET MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention