BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURVED PLATE, 5 HOLES, LEFT

    MDR report key: 3201040 · Received July 2, 2013

    Report

    Report Number
    0008010177-2013-00144
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED AND ACCORDING TO THE X-RAYS, THE PLATE WAS BROKEN. BECAUSE THE DEVICE WAS NOT RETURNED (HOSPITAL POLICY), NEITHER A VISUAL, FUNCTIONAL OR DIMENSIONAL INSPECTION COULD BE PERFORMED. THE X-RAYS SHOWED AN EXPANDED RESECTION ARTHRODESIS OF THE HALLUX METATARSOPHALANGEAL JOINT IN COMBINATION WITH RESECTION OF ALL HEADS OF THE METATARSAL BONE (CLAYTON-SURGERY). THE BREAKAGE OF THE PLATE SEEMS TO BE A TYPICAL BREAKAGE AS A RESULT OF MATERIAL FATIGUE DUE TO OVERLOAD CONDITION AND INSUFFICIENT HEALING. FURTHERMORE, IN THE EVENT DESCRIPTION IS STATED THAT THE PATIENT WAS NONCOMPLIANT AND WALKED BAREFOOT. THEREFORE THE ROOT CAUSE CAN BE ATTRIBUTED TO AN OVERLOAD CONDITION, WHICH LED TO THE BREAKAGE OF THE PLATE. AS PER STATISTICAL EVALUATION, NO INDICATIONS WERE FOUND FOR ANY SYSTEMATIC, DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION AS IT WAS KEPT BY THE HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT BROKE PLATE AND SCREWS IN FOOT AND THE SURGEON REVISED. SALES REP STATES THAT WHILE SPEAKING WITH THE SURGEON, PATIENT ADMITTED TO BEING NONCOMPLIANT AND WALKED AROUND BAREFOOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT BROKE PLATE AND SCREWS IN FOOT AND THE SURGEON REVISED. SALES REP STATES THAT WHILE SPEAKING WITH THE SURGEON, PATIENT ADMITTED TO BEING NONCOMPLIANT AND WALKED AROUND BAREFOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301709 CURVED PLATE, 5 HOLES, LEFT IMPLANT HRS STRYKER OSTEOSYNTHESIS-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR