BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01904

    MDR report key: 3043542 · Received April 9, 2013

    Report

    Report Number
    2520274-2013-01904
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ET.AL: TETSURO YASUI,MD,PHD, MATTHISAS MISKA, MD, ARNO FRIGG, MD, AND VICTOR VALDERRABANO MD, PHD. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A LITERATURE RESEARCH WAS REPORTED: THE JOURNAL OF FOOT AND ANKLE SURGERY: SOLID BOLT FIXATION OF THE MEDIAL COLUMN IN CHARCOT MIDFOOT ARTHROPATHY WITH POSTER: MARTIN WIEWIORSKI MD ET.AL: CHARCOT MEDIAL COLUMN AND MIDFOOT DEFORMITIES ARE ASSOCIATED WITH ROCKER BOTTOM FOOT, RECURRENT PLANTAR ULCERATION AND CONSEQUENT INFECTION. THE PRIMARY GOAL OF SURGICAL INTERVENTION IS TO REALIGN AND STABLILIZE THE PLANTAR ARCH IN A SHOE-ABLE PLANTIGRADE ALIGNMENT. EIGHT CASES OF SOLID INTRAMEDULLARY BOLT FIXATION FOR SYMPTOMATIC CHARCOT NEUROARTHROPATHY WERE REVIEWED. THE DEFORMITY WAS CAUSED BY DIABETIC NEUROPATHY IN SEVEN CASES 87.5 PERCENT AND ALCOHOLIC NEUROPATHY IN ONE CASE 12.5 PERCENT. NO BOLT BREAKAGE WAS OBSERVED AND NO CASES OF RECURRENT OR RESIDUAL ULCERATION OCCURRED DURING THE OBSERVATION PERIOD. NO CASES RESULTED IN LIMB AMPUTATION, WITH ALL PATIENTS ABLE TO WALK AT LEAST ONE BLOCK WITH A CANE. BOLT REMOVAL PERFORMED IN THREE CASES DUE TO AXIAL MIGRATION OF THE BOLT INTO THE ANKLE JOINT AND ONE BECAUSE OF INFECTION. RESULTS OF THE PRESENT REVIEW SUGGEST THAT A SOLID INTRAMEDULLARY BOLT PROVIDES REASONABLE FIXATION FOR THE REALIGNMENT OF THE MEDIAL COLUMN IN CASES OF CHARCOT NEUROARTHROPATHY. THIS IS CASE 6: FOLLOW UP MONTHS 16: AXIAL MIGRATION INTO ANKLE JOINT: BOLT REMOVAL. THIS IS 1 OF 1 REPORTS FOR COMPLAINT 32688. MED WATCHES FOR THIS ARTICLE: 2520274-2013-01903, CASE 5, 2520274-2013-01904, CASE 6, 2520274-2013-01905, CASE 7, 2520274-2013-01906, CASE 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144918 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention