BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINE OSTEOTOMY

    MDR report key: 15792648 · Received November 14, 2022

    Report

    Report Number
    3012086398-2022-00001
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    January 14, 2022
    Report Date
    November 9, 2022
    Manufacturer
    BODYCAD LABORATORIES, INC
    Product Code
    HRS
    UDI-DI
    00688346002140
    PMA / PMN Number
    211646
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A ROUTINE APPOINTMENT, THE DOCTOR NOTICED ON THE X-RAY THAT 3 SCREWS WERE MIGRATING. THE SCREWS THAT HAVE MIGRATED ARE THE SCREWS AT POSITION D, E AND F. NO INFECTION IS PRESENT. NO INFECTION IS PRESENT. ALSO WE SEE A FRACTURE ON THE OPPOSITE SIDE OF THE CORTEX. A SECOND SURGERY WAS PERFORMED TO REMOVE TWO OF THE THREE SCREWS IN PLACE AND ONE SCREW WAS RE-SCREWED. INVESTIGATION COULD NOT BE COMPLETED, NO DEVICE WAS RETURNED. HOWEVER , IT WAS NOTED THAT THE DEVICE HAD NO DEFECT AND REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE EVENT WAS NOT CAUSED BY WRONG LABELING OR WRONG INSTRUCTIONS FOR USE. BODYCAD CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED AND A FOLLOW-UP MEDICAL DEVICE REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    SCREWS BACKING UP. DURING A ROUTINE APPOINTMENT, THE DOCTOR NOTICED ON THE X-RAY THAT 3 SCREWS WERE MIGRATING. NO INFECTION IS PRESENT. NOTE ALSO THAT WE SEE A FRACTURE ON THE OPPOSITE SIDE OF THE CORTEX. WE SEE A SMALL FRACTURE INITIATION ON THE POST-OP PHOTO AND IT SEEMS TO HAVE WORSENED ON THE 6 WEEK POST-OP PHOTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211606 FINE OSTEOTOMY PLATE, FIXATION, BONE. SCREW, FIXATION, BONE. HRS BODYCAD LABORATORIES, INC 015-000 00688346002140

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention