BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE)

    MDR report key: 4103012 · Received September 19, 2014

    Report

    Report Number
    0008010177-2014-00266
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD BE CONFIRMED; THE SCREWS ARE BROKEN. THE INVESTIGATION RESULTS SHOW THAT TOO HIGH TORSIONAL AND TENSILE FORCES, WHEREAS THE TORSIONAL FORCES PREVAILED, ACTED ON THE SCREWS AND LED TO THE FAILURE IN FORCED RUPTURE MODE DURING THE INSERTION. THE ROOT CAUSE OF THE FAILURE COULD BE ATTRIBUTED TO THE SCREWS BEING FORCIBLY FURTHER TURNED AFTER THEY HAD CONTACTED THE PLATE. INDICATIONS FOR MATERIAL OR MANUFACTURING RELATED PROBLEMS WERE NOT FOUND IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENT CASE, TWO SCREWS BROKE OFF IN THE PATIENTS SKULL. THE SCREW WAS ENGAGED AND THE HEAD BROKE OFF. THE SCREWS REMAIN IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENT CASE, TWO SCREWS BROKE OFF IN THE PATIENTS SKULL. THE SCREW WAS ENGAGED AND THE HEAD BROKE OFF. THE SCREWS REMAIN IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581672 BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE) IMPLANT JEY STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1