BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTA IMPLANT SET

    MDR report key: 3994724 · Received June 11, 2014

    Report

    Report Number
    9615741-2014-00029
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 29, 2014
    Manufacturer
    NEWDEAL S.A.
    Product Code
    JDS
    PMA / PMN Number
    K091788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON PERFORMED A REVISION SURGERY (OF AN UNK DEVICE). DURING SURGERY THE SURGEON DISCOVERED A SHORTAGE OF THE PANTA SCREWS AND THE SIZE 10 PANTA NAIL. THE SURGEON HAD TO OVER REAM ONE BIGGER SIZE IN A SMALL BONE WITH THE RISK OF PENETRATING THE TIBIAL CORTEX AND HE HAD TO CUT THE SCREWS. ADDITIONAL INFO RECEIVED ON (B)(6) 2014. THE PATIENT IS (B)(6) WITH MULTI DEFORMITIES DUE TO A "RENAL PROBLEM." HER LEFT HIND FOOT WAS GROSSLY UNSTABLE AND WAS PREVIOUSLY OPERATED ON IN ANOTHER FACILITY WITH AN 'UNK' NAIL. SHE PRESENTED TO THE SURGEON WITH AN EXPOSED SCREW AND A FAILED FUSION. THE SURGEON REMOVED THE HARDWARE OF THE PREVIOUSLY PERFORMED HIND FOOT FUSION AND USED A PANTA NAIL AND THE HEAD OF THE PATIENT FEMUR AS ALLOGRAFT. DUE TO THE SHORTAGE OF THE DEVICES REPORTED BY THE SURGEON, HE HAD TO CUT THE SCREWS AND THE SURGERY TIME WAS INCREASED ABOUT ONE HOUR. THERE WAS NO INJURY OR ADVERSE CONSEQUENCE TO THE PATIENT REPORTED. THE SURGEON REPORTED THAT HE HAD 'ENOUGH EXPERIENCE WITH PANTA NAIL AND WAS ABLE TO MANAGE THE PROBLEM.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346142 PANTA IMPLANT SET NA JDS NEWDEAL S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR PANTA NAIL SIZE 10| PANTA SCREWS