BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLATE, MP, 6 HOLE, CURVED, BAR LENGTH 12.6MM, BAR WIDTH 2.35MM

    MDR report key: 3962789 · Received July 29, 2014

    Report

    Report Number
    0008010177-2014-00193
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 14, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED. THE INVESTIGATION SHOWS THAT THE PLATES BROKE IN LOW CYCLE FATIGUE MODE BY EXCEEDING THE MATERIAL STRENGTH AFTER A FEW CYCLES UNDER PARTIALLY VERY HIGH FORCES. THE INVESTIGATION WITH SEM SHOWS ON THE FRACTURED SURFACES THE APPEARANCE OF A LOW CYCLE FATIGUE RUPTURE. MUCH EVIDENCE OF FORCED RUPTURE AND SECONDARY CRACKS ALSO EXIST. IN ADDITION PREVALENT SWINGING LINES OF A FATIGUE BREAKAGE ARE VISIBLE TO SOME EXTENT. THE ROOT CAUSES OF THE FAILURES COULD HAVE BEEN ONE OR REPEATED POWERFUL DYNAMICALLY OVERLOAD OF THE FRACTURE AREA OF THE PLATES. AS STATED IN THE IFU, ¿THE SURGEON SHOULD DISCUSS THE EXPECTATIONS OF SURGERY INHERENT IN THE USE OF THE PRODUCT WITH THE PATIENT. PARTICULAR ATTENTION SHOULD BE GIVEN TO A DISCUSSION POSTOPERATIVELY, PROPER POST-OPERATIVE DIET CONSISTING OF SOFT FOODS, AND THE NECESSITY FOR PERIODIC MEDICAL FOLLOW-UP.¿ HOWEVER, ACCORDING TO THE REPORTED EVENT THE PATIENT HAD BEEN INCOMPLIANT EATING UNAUTHORIZED FOOD WHICH MOST LIKELY CAUSED THE DETECTED OVERLOAD AND SUBSEQUENTLY LED TO THE BREAKAGES OF THE PLATES. INDICATIONS FOR MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE NOT FOUND IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    SALES REPRESENTATIVE RECEIVED A CALL FROM THE DOCTOR STATING THAT HE WAS NEEDED IN A CASE WHERE A PATIENT WAS NON COMPLIANT AND EATING UNAUTHORIZED FOOD WHICH FRACTURED PLATES (ON BOTH SIDE OF JAW) THAT WERE IMPLANTED AT AN EARLIER DATE.

    Description of Event or Problem · 1

    SALES REPRESENTATIVE RECEIVED A CALL FROM THE DOCTOR STATING THAT HE WAS NEEDED IN A CASE WHERE A PATIENT WAS NON COMPLIANT AND EATING UNAUTHORIZED FOOD WHICH FRACTURED PLATES (ON BOTH SIDE OF JAW) THAT WERE IMPLANTED AT AN EARLIER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441943 BONE PLATE, MP, 6 HOLE, CURVED, BAR LENGTH 12.6MM, BAR WIDTH 2.35MM IMPLANT JEY STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1