BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURE-LOK EXTENDED TAB PEDICLE SCREW SYSTEM

    MDR report key: 17552763 · Received August 15, 2023

    Report

    Report Number
    3005739886-2023-00037
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    July 19, 2023
    Report Date
    July 21, 2023
    Manufacturer
    PRECISION SPINE, INC
    Product Code
    HXI
    UDI-DI
    00840019922654
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B2: OTHER SERIOUS OR IMPORTANT EVENTS - RETAINED FOREIGN OBJECT (TIP OF K-WIRE LEFT IN PATIENT'S BONE). H3: DEVICE EVALUATION - WITHOUT THE OPPORTUNITY TO EXAMINE THE REMAINDER OF THE BROKEN K-WIRE, NO CONCLUSIONS CAN BE DRAWN REGARDING THE ROOT CAUSE. WITHOUT LOT IDENTITY, DEVICE HISTORY REVIEW AND LOT SPECIFIC COMPLAINT HISTORY REVIEW ARE NOT POSSIBLE. TWO-YEAR COMPLAINT HISTORY REVIEW FOUND THIS TO BE THE ONLY REPORT OF BREAKAGE FOR THIS PART NUMBER. NO CORRECTIVE ACTIONS ARE RECOMMENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2023, UTILIZING THE REFORM TI MIS CT PEDICLE SCREW SYSTEM. WHILE THE SURGEON WAS TRYING TO REMOVE THE K-WIRE, NI BLUNT/THREADED (HXI-48-0003) FROM THE SECOND SCREW AT L4, IT BROKE CLEAN AT THE "KNURLED" PART FROM THE SMOOTH PART. NO ATTEMPT WAS MADE TO TRY TO RETRIEVE THE BROKEN PIECE, WHICH REMAINS IN THE PATIENT'S PEDICLE. MORE CARE WAS TAKEN WITH THE FINAL POSITIONING OF THE SCREW TO ENSURE THE BROKEN TIP DID NOT ADVANCE ANY MORE WITH THE SCREW BEING ADVANCED. THE SURGERY AS COMPLETED WITH OPTIMAL OUTCOME WITHOUT DELAY. THE REMAINDER OF THE K-WIRE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893449 SURE-LOK EXTENDED TAB PEDICLE SCREW SYSTEM K-WIRE HXI PRECISION SPINE, INC 00840019922654

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other