BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVOX OBLIQUE LATERAL SPINAL SYSTEM

    MDR report key: 12056021 · Received June 24, 2021

    Report

    Report Number
    1030489-2021-00844
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    December 1, 2020
    Report Date
    June 24, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MAX
    UDI-DI
    00643169639607
    PMA / PMN Number
    K152277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: PART # 2161001, LOT # NM18G004 VISUAL AND OPTICAL INSPECTION REVEALED THE ENTIRE THREADED TIP OF THE INSTRUMENT HAS BEEN BROKEN OFF, ONLY A HALF THREAD REMAINS. NO SURFACE DEFECT IDENTIFIED THAT COULD CONTRIBUTE TO CRACK PROPAGATION. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE FINDS A FAIRLY BRITTLE FRACTURE WITH NO INDICATION OF FATIGUE CONSISTENT WITH OVERLOAD. THIS TYPE OF DAMAGE IS CONSISTENT WITH BEND STRESS OVERLOAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT THAT OCCURRED DURING L3/4 DLIF PROCEDURE IN A PATIENT DIAGNOSED WITH L3/4 DEGENERATIVE SYMPTOMS. IT WAS REPORTED THAT THE SHAVER BROKE AND WHILE TAMPING THE IMPLANT INTO THE DISC SPACE, INADVERTENTLY CAUSED THE IMPLANT TO BECOME LOOSE ON INSERTER CAUSING AN OVER ROTATION OF THE INSERTER AND CAUSED DAMAGE. THE SHAVER SNAPPED WHEN TWISTING. PATIENT DID NOT HAVE ANY INJURY / COMPLICATION. PRODUCTS WILL BE RETURNED AND WILL NOT BE REPLACED WITH THE MEDTRONIC PRODUCT IN FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957973 PIVOX OBLIQUE LATERAL SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC SOFAMOR DANEK USA, INC 2161001 NM18G004 00643169639607

    Patients

    Seq Age Sex Outcome Treatment
    1