BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP ENDO-EXO MEDULLARY SYSTEM

    MDR report key: 18320295 · Received December 13, 2023

    Report

    Report Number
    3000327445-2023-00007
    Event Type
    Injury
    Date Received
    December 13, 2023
    Report Date
    December 7, 2023
    Manufacturer
    ORTHOPEDIATRICS CANADA ULC DBA PEGA MEDICAL
    Product Code
    HSB
    PMA / PMN Number
    K111232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS RECEIVED AS A COLLECTION OF CLINICAL DATA AND FEEDBACK ROM DR. (B)(6) RECEIVED IN NOVEMBER 20. THE CLINICAL DATA CONTAINED THE DATA FROM 26 PATIENTS. AMONG THESE PATIENTS, ONE EXPERIENCED AN IMPLANT FAILURE REQUIRING A REVISION. THE INITIAL SURGERY OCCURRED IN (B)(6) 2019, BUT THE FAILURE WAS 4 YEARS LATER (IN OCTOBER 2023) WHEN THE PATIENT SUFFERED A BONE FRACTURE. THE FRACTURE WAS IN THE SUBTROCHANTERIC AREA, AND THE PATIENT HAD A PROXIMAL OSTEOTOMY THAT HAD NEVER CONSOLIDATED IN THAT REGION. THE PATIENT SUFFERED FROM OI TYPE III, WAS OVERWEIGHT (70 KG), AND WAS AMBULATING ON A NON-UNION. DR. (B)(6)ALSO MENTIONED THAT THE PATIENT HAD A "VERY THIN IMPLANT (4.8MM) FOR THE PATIENT'S WEIGHT, BUT THE DIAMETER OF THE BONE IS VERY THIN". THE MAXIMUM WEIGHT FOR A 4.8 IMPLANT IS ALSO 40 KG. AT THE TIME OF THE FAILURE, THE PATIENT WAS ABOUT TWICE THAT WEIGHT (70 KG). WHILE INTRAMEDULLARY NAILS, SUCH AS THE GAP IMPLANT, ARE DESIGNED TO PROVIDE STRUCTURAL SUPPORT AND DISTRIBUTE BODY LOAD TO PREVENT OR DELAY FRACTURES, THIS CASE PRESENTED CHALLENGES. THE NON-UNION IN THE PATIENT'S BONE MEANT THAT THE IMPLANT BORE A SIGNIFICANTLY HIGHER LOAD THAN INTENDED. ADDITIONALLY, THE PATIENT'S WEIGHT EXCEEDED THE RECOMMENDED LIMIT OUTLINED IN THE INSTRUCTIONS FOR USE (IFUS). FURTHERMORE, OI PATIENTS OFTEN HAVE SMALL BONE CANALS, LIMITING IMPLANT SIZE OPTIONS. IN THIS INSTANCE, THE LATERAL VIEW INDICATED PARTICULARLY THIN BONE, INCREASING THE RISK OF IMPLANT BREAKAGE AS THE STRENGTH OF THE IMPLANT IS CONSTRAINED BY THE DIAMETER ACCEPTABLE TO THE BONE CANAL. IN CONCLUSION, THE GAP NAIL BEHAVED WITHIN NORMAL PARAMETERS; COMPLICATIONS AROSE DUE TO INHERENT BONE DYSPLASIA RESULTING IN PERSISTENT NON-UNION AND INCREASED STRESS ON THE BONE AS THE PATIENT GREW. CONSEQUENTLY, THESE CASES ARE NOT CLASSIFIED AS MALFUNCTIONS OR DEFICIENCIES OF THE DEVICE.

    Description of Event or Problem · 0

    A GAP NAIL WAS FOUND BROKEN IN A PATIENT WITH OSTEOGENESIS IMPERFECTA AFTER 4 YEARS OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260975 GAP ENDO-EXO MEDULLARY SYSTEM GAP NAIL HSB ORTHOPEDIATRICS CANADA ULC DBA PEGA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention