BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM X 45MM S-LOK CANN PLY SCREW

    MDR report key: 4112872 · Received September 17, 2014

    Report

    Report Number
    3005739886-2014-00040
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    MNH
    PMA / PMN Number
    K071438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS, BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A L4-L5 360 WITH DECOMPRESSION POSTERIORLY WITH BILATERAL PEDICLE SCREWS ON (B)(6) 2014. FOLLOWING IMPLANTATION OF THE SLC6454 S-LOK CANNULATED POLYAXIAL SCREW AND PLACEMENT OF THE ROD, THE SL1000 LOCKING CAP SCREW WOULD NOT FINAL TIGHTEN. MULTIPLE CAPS WERE TRIED AND A NEW ROD WAS ALSO PLACED, BUT FINAL TIGHTENING OF A LOCKING CAP WAS AGAIN UNSUCCESSFUL. THE PEDICLE SCREW WAS THEN REMOVED AND A NEW SCREW IMPLANTED. THE ROD AND LOCKING CAP SCREW WERE PLACED AND TIGHTENED WITH NO FURTHER ISSUE. A FORTY (40) MINUTE DELAY TO THE PROCEDURE RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577054 6.5MM X 45MM S-LOK CANN PLY SCREW MNH, MNI MNH PRECISION SPINE, INC. SLC6545 8480PS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R