BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAW 20.1X21.4X4X0.6MM F/PIEZOELECTRIC SY

    MDR report key: 7141387 · Received December 21, 2017

    Report

    Report Number
    8030965-2017-50774
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    January 1, 2017
    Report Date
    November 21, 2017
    Manufacturer
    SATELEC S.A.S, ACTEON GROUP
    Product Code
    HWE
    UDI-DI
    07611819428737
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEGAL MANUFACTURER AND LOCATION WERE DOCUMENTED AS DEPUY SYNTHES PRODUCTS LLC IN THE INITIAL REPORT. THE LEGAL MANUFACTURER AND LOCATION HAVE BEEN UPDATED TO SATELEC S.A.S, ACTEON GROUP, CONTACT OFFICE NAME/ADDRESS HAS BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECT LEGAL MANUFACTURER. 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

    THE MANUFACTURING LOCATION WAS UNKNOWN. DEVICE MANUFACTURE DATE IS UNKNOWN. THE DEVICE SERIAL OR LOT NUMBER IS UNKNOWN AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT MAXILLARY SEGMENTAL OSTEOTOMY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE OVERHEATED WHILE IN USE CAUSING A BURN TO THE PATIENT'S LIP. IN FOLLOW UP WITH THE CLINICIAN, IT WAS REPORTED THAT THE EVENT CAUSED A SCAR OF THE RIGHT COMMISSURE/CHEEK REGION AND WAS TREATED WITH EXCISION OF THE TISSUE, SUTURING, ANTIBIOTICS AND SILICON SHEETS FOR SCARRING. IT WAS REPORTED THAT THE PATIENT WAS HEALING WELL WITH KELOID AND REPORTED TO HAVE A FACIAL SCAR. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919754 SAW 20.1X21.4X4X0.6MM F/PIEZOELECTRIC SY INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH AWL HWE SATELEC S.A.S, ACTEON GROUP 07611819428737

    Patients

    Seq Age Sex Outcome Treatment
    1