BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIM - THE SIMPLE LOCKING INTRA MEDULLARY SYSTEM

    MDR report key: 17136944 · Received June 15, 2023

    Report

    Report Number
    3000327445-2023-00003
    Event Type
    Injury
    Date Received
    June 15, 2023
    Report Date
    June 15, 2023
    Manufacturer
    PEGA MEDICAL INC
    Product Code
    HSB
    PMA / PMN Number
    K143355
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PEGA MEDICAL BECAME AWARE OF THIS FAILURE THROUGH COLLECTION OF CLINICAL DATA AND FEEDBACK FROM MONTREAL SHRINERS HOSPITALS FOR CHILDREN IN A STUDY OF 21 PATIENTS. A SLIM ROD (DIAMETER AND LENGTH UNKNOWN) WAS INSERTED IN THE LEFT TIBIA OF A 20-YEAR-OLD PATIENT (AGE AT INITIAL SURGERY) WITH OI TYPE 4. THE NAIL BROKE AROUND 2.5 YEARS AFTER INITIAL SURGERY. THE X-RAY DONE 2.5 YEARS AFTER THE IMPLANTATION SHOWED THAT OSTEOTOMY SITE WAS NOT HEALING, AND THE NAIL PENETRATED THE ANTERIOR TIBIAL CORTEX. ALSO, THE DISTAL SEGMENT OF THE BONE LOOKED MORE DEFORMED. THE MOMENT AT WHICH THE NAIL BROKE IS UNKNOWN. AS THE OSTEOTOMY SITE WAS NOT HEALING AFTER 2.5 YEARS OF IMPLANT INSERTION, IT CAN BE ASSUMED THAT THE BONE CONSOLIDATION WAS NOT ACHIEVED. IT IS LIKELY THAT THE BONE NON-UNION CAUSED FATIGUE FAILURE OF THE SLIM ROD DUE TO CYCLIC CANTILEVER FORCES. BONE GROWTH COMBINED WITH THE PROGRESSIVE DISTAL DEFORMATION OF THE BONE EXPOSED THE NAIL TO AN INCREASED LOADING. THE SURGEON, DR. (B)(6), INDICATED IN A CONVERSATION WITH THE COMPANY REP (LA) THAT THIS IS AN EXPECTED TYPE OF COMPLICATION FOR THIS PATIENT CONDITION (OSTEOGENESIS IMPERFECTA) CONSIDERING THE WEAKNESS OF THE BONE. CONSIDERING THE ABOVE ASSESSMENT, THIS FAILURE IS NOT CONSIDERED A MALFUNCTION OR A DEFICIENCY OF THE DEVICE SINCE THE IMPLANT IS NOT DESIGNED TO RESIST CONTINUOUS CYCLIC LOADING IF BONE CONSOLIDATION IS NOT ACHIEVED. THE SLIM NAIL HAS BEHAVED NORMALLY, AND THE FATIGUE FRACTURE OF THE NAIL WAS DUE TO THE ADDITIONAL CYCLIC STRESSES PRODUCED BY PROGRESSIVE GROWTH OF THE BONE. THE PRODUCT IFU DOCUMENT PUTS AWARENESS OF THIS RISK: "DEVICE BREAKAGE OR DAMAGE CAN OCCUR WHEN IMPLANT IS SUBJECTED TO INCREASED LOADING ASSOCIATED WITH DELAYED UNION, NON-UNION, OR INCOMPLETE HEALING."

    Description of Event or Problem · 0

    A SLIM NAIL IMPLANTED IN LEFT TIBIA WAS FOUND BROKEN IN A 20-YEAR-OLD PATIENT WITH OI TYPE 4 AROUND 2.5 YEARS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815331 SLIM - THE SIMPLE LOCKING INTRA MEDULLARY SYSTEM SLIM NAIL HSB PEGA MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Required Intervention