BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APELO MIS PEDICLE SCREW SYSTEM

    MDR report key: 2934545 · Received January 28, 2013

    Report

    Report Number
    3003855635-2013-00002
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ATLAS SPINE, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COMPANY REP WAS PRESENT DURING SURGERY. SURGEON HAD DIFFICULTY GETTING LOCKING COLLAR DOWN. ON (B)(6) 2013 THERE NOTIFICATION THAT A REVISION SURGERY WAS TO OCCUR BECAUSE OF POSSIBLE PEDICLE BREACH. PT WAS COMPLAINING OF NUMBNESS AND PAIN. AFTER REVISION, IT WAS NOTED THAT PEDICLE WAS NOT BREACHED, BUT FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37810 APELO MIS PEDICLE SCREW SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB ATLAS SPINE, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention