BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP ENDO-EXO MEDULLARY SYSTEM

    MDR report key: 12218708 · Received July 23, 2021

    Report

    Report Number
    3000327445-2021-00005
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    June 25, 2021
    Report Date
    July 23, 2021
    Manufacturer
    PEGA MEDICAL INC.
    Product Code
    HSB
    UDI-DI
    07540194000866
    PMA / PMN Number
    K111232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY THE REPORTER INDICATED THAT THE PATIENT WAS TOLD TO PARTIALLY WEIGH BEAR WITH SUPPORT UNTIL THERE WAS BONE HEALING, AND WEAR AN ORTHOTIC BOOT. DESPITE THE INDICATIONS TO THE PATIENT, HE WENT FOR A LONG UNSUPPORTED WALK AND EVEN CLIMBED A SET OF STAIRS. PROBABLY, THE BONE WAS NOT HEALED BY THE TENTH-WEEK POST-OP, WHICH MOST LIKELY LEAD TO IMPLANT FAILURE. THE NATURE OF THE CASES WHERE THE GAP NAILS ARE FREQUENTLY USED (OSTEOGENESIS IMPERFECTA, TIBIAL PSEUDOARTHROSIS, OR OTHER SKELETAL DYSPLASIAS) INCREASES THE RISK OF DEVICE FAILURE WHEN THE POST-OPERATIVE INSTRUCTIONS ARE NOT FOLLOWED. IF WEIGHT LIMITATIONS AND POST-OPERATIVE PARTIAL WEIGHT-BEARING ARE NOT CONSIDERED, THE RISK OF FAILURE MAY INCREASE.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE GAP ENDO-EXO MEDULLARY SYSTEM NAIL GAP-56-28 WAS IMPLANTED IN THE TIBIA OF A PATIENT WITH CONGENITAL TIBIAL PSEUDOARTHROSIS. THE NAIL WAS REPORTED BROKEN ON (B)(6) 2021, 10 WEEKS AND FOUR DAYS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112689 GAP ENDO-EXO MEDULLARY SYSTEM GAP NAIL HSB PEGA MEDICAL INC. GAP-N56-28 121218-011 07540194000866

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other