BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFORM PEDICLE SCREW SYSTEM

    MDR report key: 20966556 · Received December 18, 2024

    Report

    Report Number
    3005739886-2024-00070
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    March 25, 2024
    Report Date
    November 22, 2024
    Manufacturer
    PRECISION SPINE, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B2 OTHER SERIOUS OR IMPORTANT MEDICAL EVENT - TWO HOUR SURGICAL DELAY. D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER - THIS PRODUCT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THE UDI REQUIREMENTS. H3 DEVICE EVALUATION IS NOT POSSIBLE AT THIS TIME AS THE PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURER. REVIEW OF DEVICE HISTORY RECORDS FOUND (B)(4) PIECES OF THIS LOT WERE RELEASED FOR DISTRIBUTION ON 08/21/20214 WITH NO DEVIATION OR ANOMALIES. TWO-YEAR COMPLAINT HISTORY REVIEW DID NOT IDENTIFY A TREND FOR REPORTS OF THIS NATURE FOR THIS PART NUMBER. NO CONCLUSIONS CAN BE DRAWN, NO CORRECTIVE ACTIONS A RECOMMENDED. SHOULD THE PRODUCT BE RETURNED, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A THORACOLUMBAR PROCEDURE WAS PERFORMED ON (B)(6) 2024, IN KUWAIT. DURING THE PROCEDURE THE TIP BROKE ON TWO (2) CL ROD INSERTERS (63-SP-9005), TWO INSERTER ASSEMBLY (44-9001) ONE T25, LOCK-SCREW TORQUE DRIVER, REFORM (39-RD-0060), ONE T20, POLYAXIAL DRIVER, REFORM DEGEN (39-SP-0700) AND ONE TAP, AWL-IN-ONE, PERC 5.5 MM (63-4100-55). THE PROCEDURE WAS DELAYED BY TWO HOURS WHILE AWAITING AN INSTRUMENT AND IMPLANT SET FROM A COMPETITOR. INFORMATION PROVIDED INDICATES THAT NO PATIENT HARM RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022607 REFORM PEDICLE SCREW SYSTEM SCREWDRIVER HXX PRECISION SPINE, INC 39-RD-0060 3221MM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O