BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T2 SPINAL SYSTEM

    MDR report key: 8153714 · Received December 11, 2018

    Report

    Report Number
    1030489-2018-01637
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 11, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MQP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: (PRODUCT ID: 9391322, LOT#: UM13F031, UDI#: (B)(4), 510K: K100976) AND (PRODUCT ID: 9401304, LOT#CA12L048, UDI#: (B)(4), 510K: K100976). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH BURST FRACTURE AT L1 AND UNDERWENT ANTERIOR LUMBAR FIXATION. DURING THE SURGERY, THE CAGE WAS TAPPED BY A PLASTIC HAMMER AND INSERTED INTO L1 VERTEBRAL BODY,THE CAGE WAS ALREADY LENGTHENED AND IT SEEMED THAT THE TH12 LOWER ENDPLATE WAS FRACTURED ABOUT 5MM. IT WAS CONSIDERED THAT THE PRODUCTS WORKED PROPERLY AND THEY WERE INSTALLED WITH NO MALFUNCTION. PATIENT COMPLICATIONS WERE FOUND TO BE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990085 T2 SPINAL SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other