BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSXIAL SCREW-SOLID 5.5X40MM

    MDR report key: 3952080 · Received July 18, 2014

    Report

    Report Number
    3004608878-2014-00117
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    February 2, 2012
    Report Date
    June 20, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    K091286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED "SCREW HEAD DISLOCATED FROM SHAFT, PT REQUESTED HARDWARE BACK." ON (B)(6) 2014, ADD'L INFO WAS RECEIVED FROM THE DISTRIBUTOR WHO REPORTED THE INITIAL SURGERY WAS IN 2011. THE DISLOCATED SCREW WAS REMOVED ON (B)(6) 2014. ADD'L INFO WAS REQUESTED BY INTEGRA. ON (B)(6) 2014, ADD'L INFO AND X-RAYS WAS PROVIDED (SEE OTHER RELEVANT HISTORY). ON (B)(6) 2014, REMOVAL OF BROKEN HARDWARE WITH THORACIC DECOMPRESSION T8-T10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423317 POLYSXIAL SCREW-SOLID 5.5X40MM CORAL MLS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA W13808

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention