BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM 5.50 POLYAXIAL EXTENDED TAB SCREW 6.00X45MM, TI

    MDR report key: 3072629 · Received April 23, 2013

    Report

    Report Number
    1526439-2013-15730
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 4, 2013
    Report Date
    April 22, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION FOUND THE INNER SADDLE COMPONENT WAS DISLODGED FROM THE POLYAXIAL SCREW. IT WAS NOTED UPON FURTHER EXAMINATION THAT THERE WERE VISUAL INDICATIONS THAT THE SADDLE WAS SWAGED . SIGNIFICANT MATERIAL DAMAGE WAS ALSO NOTED ON THE HEX DRIVE FEATURE OF THE SCREW SHANK. A REVIEW OF THE DHR IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO OBSERVED COMPLAINTS TRENDS FOR ISSUES OF THIS NATURE. ALTHOUGH THE CAUSE OF THE INNER SADDLE SEPARATION CANNOT BE POSITIVELY DETERMINED, IT IS LIKELY THAT THE SADDLE WAS SUBJECTED TO AN UNEXPECTED CIRCUMSTANCE OF SIDE LOADING DURING THE INSERTION OF THE POLYAXIAL SCREW. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT A METALLIC NOISE WAS HEARD WHEN INSERTING THE EXPEDIUM POLYAXIAL EXTENDED TAB SCREW. THE SCREW WAS REMOVED INTRA-OPERATIVELY AND THE SECTION THAT SECURES THE SCREW HEAD TO THE SHANK WAS FOUND TO BE BROKEN. ANOTHER SCREW WAS INSERTED WITHOUT ISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174985 EXPEDIUM 5.50 POLYAXIAL EXTENDED TAB SCREW 6.00X45MM, TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE AMDDWP

    Patients

    Seq Age Sex Outcome Treatment
    1