BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGER SPINE SYSTEM 5500 SERIES PEDICLE SCREW

    MDR report key: 5102333 · Received September 24, 2015

    Report

    Report Number
    3006494201-2015-00010
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    August 3, 2015
    Report Date
    August 19, 2015
    Manufacturer
    CORELINK, LLC
    Product Code
    NKB
    UDI-DI
    M72555065400
    PMA / PMN Number
    K121728
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION WERE DETERMINED AS 'DEVICE FAILURE RELATED TO PATIENT CONDITION'. THIS WAS IDENTIFIED SINCE THIS IMPLANT HAS BEEN IN THE PATIENT FOR OVER 2.5YRS, AND IT IS UNCLEAR HOW LONG THE SCREW FRACTURE HAS BEEN IN PLACE. THIS DEVICE IS INDICATED FOR TEMPORARY STABILIZATION DURING BONY FUSION, AND SINCE NO FUSION OCCURRED, THE DEVICE WAS OPERATING BEYOND ITS INTENDED APPLICATION AND CONTRIBUTING ACTIVITY OF THE PATIENT DURING THAT TIME OF USE IS UNKNOWN. THIS REPORT IS FOR THE 2ND OF 2 SCREWS THAT WERE IDENTIFIED IN THIS OCCURRENCE.

    Description of Event or Problem · 1

    (B) THE DISTRIBUTOR CALLED, IDENTIFYING THAT A REVISION SURGERY WAS COMPLETED ON (B)(6) 2015 TO REMOVE A 55065-40 (6.5MM X 40MM) PEDICLE SCREW FROM THE PATIENTS S1. THE DISTRIBUTOR IDENTIFIED THAT THE SCREW HAD BROKEN AT THE NECK OF THE SCREW BODY AND WAS REMOVED DURING A REVISION SURGERY. THE SCREWS WERE INITIALLY IMPLANTED ON (B)(6) 2013, THE DISTRIBUTOR WAS MADE AWARE OF THE REVISION SURGERY TO OCCUR ON (B)(6) 2015 AND CORELINK (THE MANUFACTURER) WAS MADE AWARE ON (B)(4) 2015. IT WAS IDENTIFIED BY THE PHYSICIAN TO THE DISTRIBUTOR THAT NO BONY FUSION HAD OCCURRED AT THE TIME THE BROKEN SCREW WAS EXPLANTED. (THIS REPORT IS FOR THE 2ND OF 2 SCREWS IDENTIFIED IN THIS SCENARIO).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632001 TIGER SPINE SYSTEM 5500 SERIES PEDICLE SCREW PEDICLE BONE SCREW NKB CORELINK, LLC 55065-40 SM50343 M72555065400

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other