BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI POLYAXIAL SCREW 7.5MM X 5.5MM X 50MM

    MDR report key: 4950769 · Received July 29, 2015

    Report

    Report Number
    1526439-2015-10660
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 6, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK061520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE (1) MIS CANNULATED POLYAXIAL SCREW [PRODUCT CODE: 1867-15-050, LOT NUMBER: ARFD91] WAS RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) FOR EVALUATION. VISUAL INSPECTION HAS CONFIRMED THE REPORTED COMPLAINT. THE SADDLE WAS DISLODGED AND WAS SEATED HIGHER THAN ITS INTENDED LOCATION AS WELL AS THE SADDLE WAS ROTATED (SEE ATTACHED PHOTOS). IT WAS ALSO NOTED THAT THE HEXALOBE FEATURE WAS DAMAGED. NO OTHER ABNORMALITIES OR DEFECTS WERE NOTED WITH THE SCREW. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. ROOT CAUSE FOR THE SADDLE BECOMING DISLODGED AND ROTATED CANNOT BE POSITIVELY DETERMINED. A POSSIBLE EXPLANATION MAY LIKELY BE THAT THE SADDLE EXPERIENCED A HIGHER THAN ANTICIPATED FORCE, POSSIBLY DURING INSERTION, CAUSING THE SADDLE TO ¿POP¿ OUT OF PLACE. THE CLATTERING NOISE NOTED BY THE SURGEON COULD POSSIBLY BE AN INDICATION OF THE SADDLE ¿POPPING¿ OUT OF PLACE IN THE SCREW HEAD. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, L4/5 INSTRUMENTATION USING VIPER2 WAS DONE FOR A PATIENT WITH LSCS. AFTER A PEDICLE SCREW WAS INSERTED AT L5, THE SURGEON TRIED TO INSERT A ROD, BUT IT COULD NOT BE INSERTED INTO THE SCREW. WHEN CHECKING THE SCREW OVER THE EXTENDER, THE SURGEON FOUND THAT THE COLLET INSIDE THE SCREW HEAD HAD COME OFF AND ROTATED, WHICH HAMPERED THE ROD INSERTION. THE SURGEON REPLACED THE SCREW WITH A NEW ONE AND COMPLETED THE PROCEDURE WITHOUT FURTHER PROBLEMS. ACCORDING TO THE SURGEON, THE SCREW AND EXTENDER SOUNDED LIKE A CLATTERING NOISE DURING SCREW INSERTION THOUGH THEY WERE SECURELY FIXED. NO SURGICAL DELAY OR HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494237 TI POLYAXIAL SCREW 7.5MM X 5.5MM X 50MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE ARFD91

    Patients

    Seq Age Sex Outcome Treatment
    1