BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5MM MANDIBLE MESH FOOT C-TYPE FOR CMF DISTRACTOR

    MDR report key: 4060171 · Received September 4, 2014

    Report

    Report Number
    2520274-2014-13423
    Event Type
    Injury
    Date Received
    September 4, 2014
    Report Date
    August 6, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    MQN
    PMA / PMN Number
    PK060138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT AND EXPLANT DATES UNKNOWN. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REPORT RECEIVED FROM THE SAFETY SURVEILLANCE TEAM FOR A SYNTHES MANDIBULAR DISTRACTOR, MDR REPORT KEY NUMBER (B)(4), DATED 10/28/2013, STATING: "A PATIENT CAME INTO THE CLINIC DUE TO HIS MANDIBULAR DISTRACTOR NOT MOVING. THE PHYSICIAN TOOK THE PATIENT INTO SURGERY UNDER FLUOROSCOPY AND GOT THE DISTRACTOR TO MOVE. A FEW DAYS LATER, THE PATIENT RETURNED TO THE CLINIC AGAIN DUE TO HIS DISTRACTOR NOT MOVING. THE PATIENT WAS TAKEN TO SURGERY. HARDWARE WAS FOUND TO BE BROKEN OFF AT THE PLATE INSERTION. ALL HARDWARE WAS REMOVED AND NEW HARDWARE WAS PLACED. THIS MANDIBULAR DISTRACTOR THAT WAS REMOVED WAS SAVED AND IS CURRENTLY AT OUR FACILITY. THE COMPANY REPRESENTATIVE WAS IN THE OPERATING ROOM WHEN THE MANDIBULAR DISTRACTOR WAS REMOVED". NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541134 1.5MM MANDIBLE MESH FOOT C-TYPE FOR CMF DISTRACTOR MANDIBLE DISTRACTION DEVICES2 MQN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention