BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L5000 TOE FILLER CUSTOM INSOLE

    MDR report key: 16026879 · Received December 21, 2022

    Report

    Report Number
    9616086-2022-00033
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    October 28, 2022
    Report Date
    January 4, 2023
    Manufacturer
    DJO LLC
    Product Code
    KYS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT ALLEGEDLY THE TOE FILLER DOES NOT COVER/FILL THE GAP OF THE AMPUTATION FROM 1-2 DIGIT IN WIDTH. THE TOE FILLER COMES OUT TOO LONG AND CAUSING AN ULCER OF 1 CM IN DIAMETER AND ENDED UP WITH AN INFECTION OF THE BONE. DOCTOR HAD TO GO IN AND AMPUTATE MORE OF THE METATARSAL DUE TO THE INFECTION ON THE RIGHT FOOT. THE SHOE WAS NOT RETURNED TO ENOVIS FOR INVESTIGATION. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    SEE D.9 , H3, H6 H10. IT WAS REPORTED THAT ALLEGEDLY THE TOE FILLER DOES NOT COVER/FILL THE GAP OF THE AMPUTATION FROM 1-2 DIGIT IN WIDTH. THE TOE FILLER COMES OUT TOO LONG AND CAUSING AN ULCER OF 1 CM IN DIAMETER AND ENDED UP WITH AN INFECTION OF THE BONE. DOCTOR HAD TO GO IN AND AMPUTATE MORE OF THE METATARSAL DUE TO THE INFECTION ON THE RIGHT FOOT. ENOVIS RECEIVED TOE FILLER BACK FOR EVALUATION. THE LAB PULLED THE ORIGINAL CAST OF THE FOOT, IT WAS CONFIRMED THE TOE FILLER WAS NOT MADE TO SPECIFICATIONS. THE POSSIBLE ROOT CAUSE COULD BE THAT DURING THE MODIFICATION PROCESS THE ASSEMBLER WAS SUPPOSED TO ADD FILLER MATERIAL TO THE 1ST AND 2ND TOE AREA OF THE AMPUTATION SITE, THE TOE FILLER WAS MADE FOR THE FIRST TOE AND NOT THE 2ND. THE TOE FILLER ALSO IS SUPPOSED TO MADE TO ELONGATE THE AREA WHERE THE FILLER MATERIAL WILL BE ADDED, AND THE DEVICE WAS MANUFACTURED DIRECTLY UP TO THE AMPUTATION AREA CAUSING PRESSURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALLEGEDLY THE TOE FILLER DOES NOT COVER/FILL THE GAP OF THE AMPUTATION FROM 1-2 DIGIT IN WIDTH. THE TOE FILLER COMES OUT TOO LONG AND CAUSING AN ULCER OF 1 CM IN DIAMETER AND ENDED UP WITH AN INFECTION OF THE BONE. DOCTOR HAD TO GO IN AND AMPUTATE MORE OF THE METATARSAL DUE TO THE INFECTION ON THE RIGHT FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2840703 L5000 TOE FILLER CUSTOM INSOLE INSOLES, MEDICAL KYS DJO LLC 17-0004-0-00000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown