BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL SCREW-SOLID 7.5X40MM

    MDR report key: 3061598 · Received April 11, 2013

    Report

    Report Number
    3004608878-2013-00064
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 11, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HWC
    PMA / PMN Number
    K091266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE ALSO INVOLVED IN THIS SURGERY: 18-12-7540, POLYAXIAL SCREW SOLID 7.5X40MM (LOT NUMBER: W10966), 18-12-7540, POLYAXIAL SCREW-SOLID 7.5X40MM (LOT NUMBER: W9324), 18-16-7540, POLYAXIAL SCREW-FENESTRATED 7.5X40MM (LOT NUMBER: W8674). TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    MALFUNCTIONING SCREWS FROM A CORAL CASE WERE REPORTED BY THE DISTRIBUTOR. THE SURGEON WAS INSERTING THE SCREW AND ONCE HE PUT PRESSURE ON THE DRIVER, THE SCREW LOCKED AT A 30 DEGREES ANGLE. USING ACCORDING TO THE SURGICAL TECHNIQUE, 4 SCREWS WERE USED BEFORE ONE WORKED. THE SURGEON JUST TOOK OFF THE SCREW AND TRIED ANOTHER ONE. SURGERY WAS COMPLETED. SURGERY TIME DID NOT EXTEND MORE THAN 10 MINUTES DUE TO THE INCIDENT. ADD'L ANESTHESIA WAS NOT ADMINISTERED DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156789 POLYAXIAL SCREW-SOLID 7.5X40MM CORAL MIS HWC INTEGRA LIFESCIENCES CORPORATION W18374

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR