BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 3769778 · Received April 9, 2014

    Report

    Report Number
    9615741-2014-00014
    Event Type
    Injury
    Date Received
    April 9, 2014
    Report Date
    March 20, 2014
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HWC
    PMA / PMN Number
    K083154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED 'MY RIGHT FOOT DORSAL PLATE BROKE (AFTER IT WAS IMPLANTED) AND WILL REQUIRE REVISION SURGERY. THE SURGERY HAS NOT BEEN SCHEDULED'. IN CONVERSATION WITH THE PT, SHE REPORTED SHE HAD SURGERY IN BOTH FEET, IN (B)(6) 2013 AND SHE CURRENTLY HAS PAIN IN HER RIGHT FOOT (WHICH SHE SAID WAS) DUE TO THE BROKEN PLATE. ON AN UNK DATE AFTER SURGERY ON HER LEFT FOOT, A SCREW BACKED OUT OF THE SECOND TOE OF HER LEFT FOOT. THE SCREW WAS REMOVED FROM THE LEFT SECOND TOE BY THE IN 2013 WITHOUT ISSUE. THE PATIENT SAID SHE HAS HAD NO FURTHER PAIN IN HER LEFT FOOT. IN DIRECT CONVERSATION WITH THE SURGEON, HE SAID HE FELT 'THERE WAS NO ISSUE WITH THE HARDWARE; THE PT OVERDID IT' AND HER FOOT DID NOT FUSE' ON (B)(6) 2014, ADD'L INFO WAS RECEIVED FROM THE DISTRIBUTOR WHO SAID THE INTEGRA DEVICE WAS FROM THE HALLU-LOCK SYSTEM THAT WAS IMPLANTED IN THE PATIENT'S LEFT FOOT ON (B)(6) 2013. A COMPETITOR DEVICE WAS IMPLANTED IN THE RIGHT FOOT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215865 NONE HWC NEWDEAL S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HALLU-LOCK SYSTEM IN LEFT FOOT| COMPETITOR (UNK) DEVICE WAS IMPLANTED IN RIGHT FOO