BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILO

    MDR report key: 19170485 · Received April 24, 2024

    Report

    Report Number
    1030489-2024-00320
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    November 9, 2023
    Report Date
    April 24, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    UDI-DI
    00885074226552
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. PRODUCT ANALYSIS PRODUCT ID # 8880009 LOT NO. # BM12E007 VISUAL INSPECTION CONFIRMED THE TORQUE HANDLE HAS BROKEN AT THE WELD. THE DAMAGE APPEARS TO BE FROM OVERLOAD CAUSED FROM EXCESSIVE FORCE PLACED ON THE HANDLE DURING USE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR L1 VERTEBRAL FRACTURE. PROCEDURE PERFORMED WAS POSTERIOR FUSION FOR L1 FRACTURE. THE LEVEL AT WHICH THE IMPLANT PERFORMED WAS TH11-L3. IT WAS REPORTED THAT THE TORQUE LIMITING HANDLE WAS BROKEN DURING THE FINAL TIGHTENING. WHEN FINAL TIGHTENING WAS PERFORMED STARTING FROM THE RIGHT TEMPORAL SIDE, THE PRODUCT WAS BROKEN WHEN THE THIRD L2 WAS FINALLY TIGHTENED. AS A REPLACEMENT, THE FINAL TIGHTENING WAS DONE USING A MODULAR FIX HANDLE & TORQUE INDICATING DRIVER, AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. DELAY IN OVERALL PROCEDURE TIME WAS LESS THAN 60 MINUTES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381959 SILO ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC 8880009 BM12E007 00885074226552

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown