BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL SCREW-SOLID 6.5X40MM

    MDR report key: 2932373 · Received January 22, 2013

    Report

    Report Number
    3004608878-2013-00013
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 21, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    KWP
    PMA / PMN Number
    K041592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE ALSO USED IN THIS SURGERY: PRODUCT ID: (B)(4) (POLYAXIAL SCREW INSERTER) X2. TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORAL TULIP AND SCREW DISASSEMBLED DURING INSERTION WITH THE DRIVER (INSERTER). THERE WAS A SPARE IMPLANT/INSTRUMENT IN THE CASE AND THE SPARE FUNCTIONED PROPERLY. SURGERY TIME WAS NOT EXTENDED MORE THAN 10 MINUTES DUE TO THE ALLEGED INCIDENT. ADDITIONAL ANESTHESIA WAS NOT ADMINISTERED DUE TO THE ALLEGED INCIDENT. SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31481 POLYAXIAL SCREW-SOLID 6.5X40MM CORAL MIS KWP INTEGRA LIFESCIENCES CORPORATION OH/USA W5316

    Patients

    Seq Age Sex Outcome Treatment
    1