BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4342291 · Received December 18, 2014

    Report

    Report Number
    2520274-2014-15345
    Event Type
    Injury
    Date Received
    December 18, 2014
    Report Date
    November 19, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FOR TREATMENT, NOT DIAGNOSIS. DORSAL MODIFIED CALCANEAL PLATE FOR EXTENSIVE MIDFOOT ARTHRODESIS, SUH, J-S, M.D., AMENDOLA, A, M.D., LEE, K-B., M.D., WASSERMAN, L. M.D., SALTZMAN, C.L. M.D. FOOT & ANKLE INTERNATIONAL. 2005 BY THE AMERICAN ORTHOPAEDIC FOOT & ANKLE SOCIETY, INC, 2005. THIS REPORT IS FOR AN UNKNOWN-NON-LOCKING CALCANEAL PLATE/UNKNOWN LOT. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, DORSAL MODIFIED CALCANEAL PLATE FOR EXTENSIVE MIDFOOT ARTHRODESIS, SUH, J-S, M.D., AMENDOLA, A, M.D., LEE, K-B., M.D., WASSERMAN, L. M.D., SALTZMAN, C.L. M.D. FOOT & ANKLE INTERNATIONAL. 2005 BY THE AMERICAN ORTHOPAEDIC FOOT & ANKLE SOCIETY, INC, 2005. THIS STUDY REPORTS THE RESULTS OF EXTENSIVE MIDFOOT FUSIONS CAN BE CHALLENGING BECAUSE OF BONE LOSS, DEFORMITY, AND SOFT TISSUE ANATOMY. THE AUTHORS REPORT A NEW TECHNIQUE USING A DORSALLY-PLACED, MODIFIED CALCANEAL PLATE BETWEEN 2000 AND 2003. MIDFOOT ARTHRODESES WITH A DORSAL CALCANEAL PLATE WERE DONE IN 10 PATIENTS. THERE WERE FIVE WOMEN AND FOUR MEN WITH AN AVERAGE AGE OF 47 YEARS (RANGE 32 TO 61 YEARS). ARTHRODESES WERE ATTEMPTED IN 62 JOINTS IN THESE NINE PATIENTS. PATIENTS WERE MAINTAINED NONWEIGHTBEARING UNTIL RADIOGRAPHS OR COMPUTED TOMOGRAPHY CONCLUSIVELY SHOWED UNION. COMPLICATIONS: ONE PATIENT DIED FROM AN UNRELATED CAUSE. ONE NONUNION WITH BROKEN SCREWS, 1 SCREW HEAD PROTRUDED THROUGH THE DORSAL SKIN IN A NEUROPATHIC DIABETIC PATIENT WHICH REQUIRED DEBRIDEMENT AND HARDWARE REMOVAL; A (B)(6) YEAR OLD FEMALE WITH DIABETES MELLITUS HAD A NON-UNION THAT REQUIRED PARTIAL HARDWARE REMOVAL; A (B)(6) YEAR OLD FEMALE WITH RESIDUAL CLUBFOOT DEFORMITY REQUIRED CALCANEOCUBOID REVISION, OUTSIDE PLATE; A (B)(6) YEAR OLD MALE WITH DIABETES MELLITUS HAD WOUND DEHISCENCE WHICH REQUIRED HARDWARE REMOVAL; A (B)(6) YEAR OLD FEMALE WITH PRIMARY OSTEOARTHRITIS THAT REQUIRED REVISION, AND 1 HARDWARE REMOVALS. THIS REPORT IS FOR SCREW HEAD PROTRUDED IN NEUROPATHIC DIABETIC PATIENT-HARDWARE REMOVAL-DEVICE INTERACTION. THIS REPORT IS FOR AN UNKNOWN-NON-LOCKING CALCANEAL PLATE. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 8 OF 8 COMPLAINT COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832051 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention