BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

    MDR report key: 18193931 · Received November 21, 2023

    Report

    Report Number
    MW5148396
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    May 11, 2013
    Report Date
    May 17, 2024
    Manufacturer
    UNK
    Product Code
    LLZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLING, STATING THAT SHE HAD A BACTERIAL INFECTION, PLASTIC PARTICLES EMBEDDED IN HER BONE, AND BONE CYSTS AFTER AN "EXPERIMENTAL" DEVICE WAS USED ON HER DURING AN ANKLE SURGERY. REPORTER STATES THE MYOSTEOTOMY SYSTEM WAS IMPROPERLY USED AND RESULTED IN LARGER AND WIDER SURGICAL INCISIONS THAN WERE NECESSARY IN ADDITION TO "PLASTIC PARTICLES" FROM THE "30 PRINTED DEVICE" BEING SHED INTO HER BODY DURING SURGERY, CAUSING BACTERIAL INFECTION AND EMBEDDING IN HER ANKLE BONE. REPORTER STATES SHE HAS DIFFICULTIES WALKING TODAY DUE TO THE USE OF THIS SYSTEM AND THE RESULTING COMPLICATIONS. REPORTER STATES SHE WOULD LIKE THE FDA TO INVESTIGATE THE MYOSTEOTOMY SYSTEM AND "CONTACT THE SWISS AUTHORITIES" BECAUSE IT IS NOT SAFE TO USE ON PATIENTS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 17-MAY-2024, FOR MW5148396. UPDATING DEVICE AND MANUFACTURER INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 31-MAY-2024, FOR MW5148396. UPDATING DEVICE NAME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 24-APR-2024 FOR MW5148396 TO UPDATE PROCODE TO LLZ..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232283 SYSTEM, IMAGE PROCESSING, RADIOLOGICAL SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ UNK
    2101779 SYSTEM, IMAGE PROCESSING, RADIOLOGICAL SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown