BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP ENDO-EXO MEDULLARY SYSTEM

    MDR report key: 7041134 · Received November 17, 2017

    Report

    Report Number
    3000327445-2017-00006
    Event Type
    Injury
    Date Received
    November 17, 2017
    Date of Event
    October 21, 2017
    Report Date
    November 17, 2017
    Manufacturer
    PEGA MEDICAL, INC.
    Product Code
    HSB
    PMA / PMN Number
    K160545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE WEIGHT OF THE PATIENT (AROUND (B)(6)) WAS WELL ABOVE THE WEIGHT LIMIT OF THE NAIL, WHICH IS AROUND (B)(6). THE COMBINATION OF HIGH LOADS DUE TO THE PATIENT'S WEIGHT EXCEEDING THE WEIGHT LIMIT OF THE DEVICE AND THE LIKELIHOOD OF EARLY WEIGHT BEARING, CAUSED THE NAIL TO FAIL PROXIMALLY AT THE DISTAL LOCKING SCREW HOLE. DUE TO ITS REDUCED DIAMETER, THE GAP NAIL IS NOT RECOMMENDED FOR EARLY FULL WEIGHT BEARING. LOAD SHARING AND PROTECTION IS NECESSARY TO ALLOW AND PROMOTE BONE HEALING. IT IS ALSO IMPORTANT TO NOTE THAT THE WEAKEST SECTION OF THE GAP NAIL IS LOCATED AT THE DISTAL HOLES WHERE LOCKING CORTICAL SCREWS ARE PLACED TO PROVIDE COMPRESSIVE AND ROTATIONAL STABILITY, THUS ALLOWING PROPER BONE HEALING OF THE FRACTURE/OSTEOTOMY.

    Additional Manufacturer Narrative · 1

    A GAP-N56-26 NAIL WAS USED TO TREAT A TEENAGER WITH OSTEOGENESIS IMPERFECTA. A FEW MONTHS POST-SURGERY THE NAIL BROKE DISTALLY, SPECIFICALLY AT THE PROXIMAL SCREW HOLE. THE SURGEON WHO REPORTED THIS INCIDENT BELIEVES THAT EARLY WEIGHT BEARING MAY HAVE BEEN THE MAIN CONTRIBUTING FACTOR FOR THE FAILURE. THE SURGEON ALSO REPORTS THAT THE INCIDENT IS NOT CATASTROPHIC, BUT THE SURGERY WILL HAVE TO BE REVISED TO REPLACE THE NAIL. THIS HAS NOT TAKEN PLACE YET AS THE PATIENT WANTS TO TRY TO WAIT TILL SUMMER BREAK DUE TO BEING IN COLLEGE OUT OF STATE.

    Description of Event or Problem · 1

    A GAP-N56-26 NAIL WAS USED TO TREAT A TEENAGER WITH OSTEOGENESIS IMPERFECTA. A FEW MONTHS POST-SURGERY THE NAIL BROKE DISTALLY, SPECIFICALLY AT THE PROXIMAL SCREW HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819755 GAP ENDO-EXO MEDULLARY SYSTEM INTRAMEDULLARY NAIL HSB PEGA MEDICAL, INC. 160506-002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention