BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PAL SPACER 10MM X 28MM 11MM HEIGHT

    MDR report key: 3182051 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03402
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 3, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    MAX
    PMA / PMN Number
    K100089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND THE LOT NUMBER WAS NOT PROVIDED, THEREFORE , A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. PLACEHOLDER.

    Description of Event or Problem · 1

    SYNTHES CANADA REPORTS AN EVENT AS FOLLOWS: PATIENT UNDERWENT A TLIF PROCEDURE AND WAS IMPLANTED WITH A T-PAL SPACER - 11MM AT L5-S1 ON (B)(6) 2013. SURGEON REPORTED THAT THERE WAS NOTHING REMARKABLE ABOUT THE CASE OR ANATOMY. SURGEON NOTED A NON-FUSION AND ON (B)(6) 2013, PERFORMED REVISION SURGERY. THE T-PAL SPACER WAS REMOVED AND REPLACED WITH A LARGER T-PAL SPACER - 13MM. XIA PEDICLE SCREWS WERE USED TO SUPPORT FROM THE BACK AT 4 LEVELS (L3-S1). THE DEVICE WAS DISCARDED BY THE HEALTH CARE FACILITY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281884 T-PAL SPACER 10MM X 28MM 11MM HEIGHT INTERVERTEBRAL FUSION DEVICE MAX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention