BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDIATRIC MANDIBULAR DISTRACTOR 2, 3X3 RIGHT PLATES, 30 MM

    MDR report key: 9764758 · Received February 27, 2020

    Report

    Report Number
    0008010177-2020-00014
    Event Type
    Injury
    Date Received
    February 27, 2020
    Date of Event
    October 23, 2019
    Report Date
    June 23, 2020
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    MQN
    PMA / PMN Number
    K181504
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BECAUSE OF THE PICTURE OF THE HARDWARE PROVIDED BY THE MOTHER OF THE PATIENT, THE DEVICES COULD BE IDENTIFIED AS 62-02333 AND 62-02332. FURTHERMORE, THE REPORTED BREAKAGES OF THE PLATES WERE CONFIRMED. THE OTHER REPORTED FAILURE MODE OF THE ADAPTER FOR THE ACTIVATION ROD BROKE THROUGH SKIN ON NECK COULD ALSO BE CONFIRMED DUE TO ANOTHER PICTURE (DISTRACTION ROD COMPLICATION) PROVIDED FOR CATALOG # 62-02333. THE EVENT WAS DISCUSSED WITH THE RELEVANT R&D DEPARTMENT. AS STATED IN THE RELATED INSTRUCTION FOR USE THE PEDIATRIC MANDIBULAR DISTRACTOR 2 IS INDICATED TO CORRECT CONGENITAL OR POST TRAUMATIC DEFECTS IN THE BODY AND RAMUS OF THE MANDIBLE OF NEONATES AND CHILDREN UP TO 4 YEARS OLD. IN THE EVENT DESCRIPTION IS MENTIONED THAT THE PATIENT WAS OLDER THAN 4 YEARS OLD. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODES WAS ATTRIBUTED TO OFF-LABEL USE. FURTHERMORE, THIS WAS CONFIRMED BY AN ADDITIONAL VOLUNTARILY REPORTED MEDICAL DEVICE REPORT (FDA) CLEARLY STATING ¿THEY USED THE DEVICE ON HER SON WITHOUT NOTIFICATION OF OFF-LABEL USE.¿ INDICATIONS FOR A DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE COULD NOT BE FOUND IN THE INVESTIGATION. THEREFORE, NO CORRECTIVE AND / OR PREVENTIVE ACTION IS DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED POST OPERATIVE, THE PRODUCT PLATES FRACTURED AND TURNING ROD BROKE THROUGH SKIN ON NECK.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. THE CATALOG NUMBER FOR THIS PRODUCT IS UNKNOWN AT THIS TIME AND WILL BE UPDATED UPON RECEIPT OF MORE INFORMATION. THIS IS IN REGARD TO THE ROD. DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED POST OPERATIVE, THE PRODUCT PLATES FRACTURED AND TURNING ROD BROKE THROUGH SKIN ON NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229315 PEDIATRIC MANDIBULAR DISTRACTOR 2, 3X3 RIGHT PLATES, 30 MM DISTRACTOR MQN STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other