BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW ASSEMBLY

    MDR report key: 3101350 · Received May 3, 2013

    Report

    Report Number
    3004608878-2013-00087
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 3, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    NKB
    PMA / PMN Number
    K091266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WAS INVOLVED IN THIS SURGERY: (B)(4) (POLYAXIAL SCREW-SOLID 5.5X50MM). TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A L5-S1 FIX FUSE, THE SET SCREW CROSS THREADED AND THE POLYAXIAL SCREW SPLAYED. THIS DISTRIBUTOR WAS NOT SURE BUT IT WAS THOUGHT THAT THE POLYAXIAL SCREW DID SPLAY AS A RESULT OF CROSS THREADED SET SCREW. THE PHYSICIAN PUT THE SCREW ON, TRIED TO COUNTER TORQUE, AND THE SET SCREW LOCKED. THE PHYSICIAN TRIED TO TAKE OFF THE COUNTER TORQUE AND IT WAS DIFFICULT TO REMOVE TORQUE HANDLE BECAUSE IT WAS BELIEVED THE SET SCREW CROSS THREADED. THE PRODUCT PROBLEM OCCURRED AT THE END OF THE SURGERY. THERE WAS NO KNOWN HARM/INJURY TO THE PATIENT. THERE WAS A SURGICAL DELAY OF 10 MINUTES. BOTH POLYAXIAL SCREW AND LOCKING SCREW WERE REPLACED AND THE REPLACEMENTS FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194547 LOCKING SCREW ASSEMBLY CORAL NKB INTEGRA LIFESCIENCES CORPORATION OH/USA W10437

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR