BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM X 40MM S-LOK POLYAXIAL SCREW

    MDR report key: 3801675 · Received April 28, 2014

    Report

    Report Number
    3005739886-2014-00024
    Event Type
    Injury
    Date Received
    April 28, 2014
    Report Date
    April 3, 2014
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    MNI
    PMA / PMN Number
    K071438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROCESS BUT NOT COMPLETE. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED IN (B)(6), THE TULIP HEAD OF THE SLP POLYAXIAL SCREW SPLAYED UPON ATTEMPTED INSERTION OF THE LOCK SCREW. THE SLP POLYAXIAL SCREW WAS REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253351 5.5MM X 40MM S-LOK POLYAXIAL SCREW MNI PRECISION SPINE, INC. 7666PM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention