BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVOX OBLIQUE LATERAL SPINAL SYSTEM

    MDR report key: 10768308 · Received November 1, 2020

    Report

    Report Number
    1030489-2020-01528
    Event Type
    Malfunction
    Date Received
    November 1, 2020
    Date of Event
    October 1, 2020
    Report Date
    November 1, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MAX
    PMA / PMN Number
    K152277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THE RAPY. IT WAS REPORTED THAT WHEN SURGEON WAS IMPLANTING THE CAGE WITH INSERTER, AND THEN BACKED THE IMPLANT OUT. HE REMOVED THE IMPLANT FROM THE INSERTER ON THE BACK TABLE, THE TIP OF THE INSERTER BROKE OFF IN THE IMPLANT. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020: WHEN THE SURGEON REMOVED THE INSERTER FROM THE IMPLANTED IMPLANT, THE TIP BROKE OFF DURING REMOVAL. THE BROKEN OFF PIECE WAS LEFT IN THE CAGE, AND WAS EASILY REMOVED BY THE SURGEON WITH SOME PICKUPS. THE PART NUMBER OF THE INSERTER WAS 2161001. THERE WERE NO COMPLICATIONS INVOLVED TO THE PATIENT. THE PATIENT OUTCOME WAS AS PLANNED WITH NO DELAY IN THE CASE. NO FRAGMENTS LEFT INSIDE. THEY TOOK C-ARM SHOT TO CONFIRM. THIS WAS HAPPENED DURING THE CASE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020: THERE WERE NO PROBLEMS WITH THE IMPLANT/CAGE. THE LOT NUMBER OF THE REPORTED INSERTER IS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020: YES, THERE WAS NO INJURY TO THE PATIENT, AND THE OUTCOME OF THE CASE WAS JUST HOW THE SURGEON PLANNED IT PRE-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232487 PIVOX OBLIQUE LATERAL SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK USA, INC 2161001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1