BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM K-WIRE LENGTH, 200MM

    MDR report key: 3827664 · Received May 7, 2014

    Report

    Report Number
    9615741-2014-00020
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    June 3, 2011
    Report Date
    May 7, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    HXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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

    THIS IS THE FOURTH REPORT OF FOUR REPORTS CONCERNING THE SAME PT (SEE MFG REPORT NUMBER 9615741-2014-00017). THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS A K-WIRE THAT WAS USED FOR FIXATION DURING SURGERY ON (B)(6) 2011. IT WAS REPORTED THE PT (A HEALTHCARE PROFESSIONAL) HAD SURGERY IN HER RIGHT FOOT DUE TO PAIN DUE TO FLAT FEET. A TALONAVICULAR FUSION, FLEXOR TENDON LIGAMENT REPAIR, AND A MEDICAL SLIDE CALCANEAL OSTEOTOMY OF THE RIGHT FOOT WAS PERFORMED ON (B)(6) 2011. AT THE TIME OF SURGERY, THREE QWIX SCREWS WERE IMPLANTED. A K-WIRE WAS USED FOR FIXATION. ON A NON-SPECIFIED DATE AFTER SURGERY THE PT SAID SHE EXPERIENCED PAIN IN HER RIGHT FOOT. IN (B)(6) 2013, PT EXPERIENCED PAIN IN HER FOOT AND A MAGNETIC RESONANCE IMAGING (MRI) WHICH REVEALED A CYST IN THE RIGHT FOOT THAT 'HAD A HOLE IN IT' AND AVASCULAR NECROSIS. PT SAID SHE 'FELT THE K-WIRE THAT WAS USED FOR THE SURGERY AND REMOVED DURING SURGERY CAUSED THE CYST IN HER RIGHT FOOT'. ON (B)(6) 2013, THE PT EXPERIENCED PAIN AND SAID SHE THOUGHT THE CYST 'BROKE' BUT A COMPUTED AXIAL TOMOGRAPHY (CAT) SCAN REVEALED THE CYST WAS PRESENT AND INCREASED IN SIZE. ON (B)(6) 2013, PT HAD SURGERY TO REMOVE THE CYST, BONE GRAFTING WAS DONE USING AUTO-GRAFT BONE FROM HER TIBIA AND A SUBTALAR FUSION WAS PERFORMED. A CAT ON (B)(6) 2014 REVEALED A FRACTURE IN THE RIGHT FOOT. PT REPORTED SHE STILL EXPERIENCES PAIN WHEN WALKING. ON (B)(6) 2014 IN DIRECT CONVERSATION, THE PT SAID SHE HAD AN APPOINTMENT WITH A DIFFERENT SURGEON SCHEDULED FOR (B)(6) 2014. ON (B)(6) 2014, PT SAID SHE PLANNED TO CANCEL THE APPOINTMENT BECAUSE SHE IS LOOKING FOR A JOB. REQUEST WAS MADE BY INTEGRA FOR ADDITIONAL INFO INCLUDING THE OPERATIVE NOTES AND DIAGNOSTIC TESTS THAT WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274976 2.5MM K-WIRE LENGTH, 200MM NA HXI NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention