BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM X 40MM S-LOK POLYAXIAL SCREW

    MDR report key: 3315414 · Received August 23, 2013

    Report

    Report Number
    3005739886-2013-00027
    Event Type
    Injury
    Date Received
    August 23, 2013
    Date of Event
    July 30, 2013
    Report Date
    July 30, 2013
    Manufacturer
    SPINAL USA, INC
    Product Code
    MNI
    PMA / PMN Number
    K071438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT REPORTED INCLUDES TWO (2) FRACTURED SCREWS FROM THE SAME PART/LOT. AS BOTH SCREWS ARE FROM THE SAME PART/LOT ONLY ONE REPORT IS BEING FILED. EVALUATION IN PROCESS. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A TLIF L4-S1 PROCEDURE ON (B)(6) 2012. REVISION WAS PERFORMED ON (B)(6) 2013 TO ADDRESS FRACTURE OF TWO POLYAXIAL SCREWS, LOCATED IN S1, THAT FRACTURED JUST ABOVE MID-SHAFT. THE DISTAL PORTION OF BOTH SCREWS WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416012 6.5MM X 40MM S-LOK POLYAXIAL SCREW PEDICLE SCREW SPINAL SYSTEM MNI SPINAL USA, INC 4193TS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R