BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D/M 10 IN SS BROAD COMP PLATE

    MDR report key: 3120494 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01717
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HRS
    PMA / PMN Number
    K922525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A DALL MILE PLATE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS INDICATE THAT FRACTURE OCCURRED THROUGH THE FOURTH FIXATION HOLE FROM ONE END OF THE PLATE. DIMENSIONAL INSPECTION NOT PERFORMED BECAUSE THERE IS NO INDICATION OF A DIMENSIONAL ISSUE. FUNCTIONAL INSPECTION NOT PERFORMED BECAUSE THE CLINICAL SITUATION CANNOT BE REPLICATED. THE MATERIAL ANALYSIS REPORT CONCLUDED THAT THE COMPRESSION PLATE FRACTURED THROUGH ONE OF THE CENTRAL FIXATION HOLES IN FATIGUE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EVALUATED. A MEDICAL REVIEW BY A CLINICAL CONSULTANT INDICATED THAT THE ROOT CAUSE FOR DEVELOPMENT OF THIS OVERLOAD CONDITION ARE PATIENT-RELATED FACTORS REGARDING DELAYED FRACTURE HEALING. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE THAT THE PLATE FRACTURED IN FATIGUE DUE TO AN OVERLOAD CONDITION RELATED TO DELAYED FRACTURE HEALING. THERE IS NO EVIDENCE THAT THE EVENT WAS MANUFACTURING RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PER PHYSICIAN AMBULATING. FRACTURE OF PLATE OCCURRED BETWEEN HOLES #5 AND 6 AT LEVEL OF THE ORIGINAL FRACTURE SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PER PHYSICIAN AMBULATING. FRACTURE OF PLATE OCCURRED BETWEEN HOLES #5 AND 6 AT LEVEL OF THE ORIGINAL FRACTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221981 D/M 10 IN SS BROAD COMP PLATE IMPLANT HRS STRYKER ORTHOPAEDICS-MAHWAH 33004801

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R