BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC MANDIBULAR DISTRACTOR ASSEMBLY, RIGHT, 24MM

    MDR report key: 14221170 · Received April 27, 2022

    Report

    Report Number
    2027754-2022-00010
    Event Type
    Injury
    Date Received
    April 27, 2022
    Report Date
    May 4, 2022
    Manufacturer
    OSTEOMED, LLC
    Product Code
    MQN
    PMA / PMN Number
    K013618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE DEVICE IS RETURNED OR FURTHER INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND A BATCH/LOT NUMBER WAS NOT PROVIDED. ATTEMPTS TO OBTAIN FURTHER INFORMATION ABOUT THE REPORTED EVENT AND PATIENT STATUS HAVE BEEN UNSUCCESSFUL. A TWO YEAR REVIEW OF CAPAS AND NCRS IDENTIFIED NO CAPAS OR NCRS RELATED TO THIS PART NUMBER. ADDITIONALLY, A TWO YEAR REVIEW OF COMPLAINT IDENTIFIED ONLY THIS EVENT REPORTED FOR THIS PART NUMBER. RISK DOCUMENTATION AND LABELING WERE REVIEWED. THE REVIEW OF RISK DOCUMENTATION DETERMINED THIS FAILURE IS ADEQUATELY CAPTURED. IN ADDITION, REVIEW OF THE IFU DETERMINED THERE GUIDANCE WITHIN THE CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND MAINTAINING DEVICE EFFECTIVENESS SECTIONS. SPECIFIC TO THIS COMPLAINT, A ROOT CAUSE CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. FURTHERMORE, THE OPERATING CONDITIONS ARE UNKNOWN, SUCH AS WHAT DEVICES WERE USED TO FACILITATE IMPLANTATION, WHAT BONE QUALITY THE PATIENT HAD (ANY CONTRAINDICATIONS), WHAT AMOUNT OF FORCE/MANIPULATION/BENDING WAS USED ON THE IMPLANT, ETC., WHICH COULD HAVE LED TO THE IMPLANT FRACTURE. IN ADDITION, IT IS UNKNOWN HOW COMPLIANT THE PATIENT WAS PER THE INSTRUCTIONS SPECIFIED IN THE IFU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON X-RAY IT APPEARED THE BODY OF THE DISTRACTOR HAD A FRACTURE ON THE RIGHT SIDE. THE LEFT SIDE APPEARED TO HAVE NO ISSUES AND WAS CONTINUING TO DISTRACT AS INTENDED. NO OTHER INFORMATION WAS PROVIDED. FOLLOW UP IS BEING CONDUCTED. THIS REPORT IS RELATED TO REPORT NUMBER 2027754-2022-00011 WHICH IS FOR THE OTHER DEVICE INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791836 LOGIC MANDIBULAR DISTRACTOR ASSEMBLY, RIGHT, 24MM EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR MQN OSTEOMED, LLC 216-0115

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other