BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPINE FUSION SYSTEM

    MDR report key: 5834488 · Received July 29, 2016

    Report

    Report Number
    3004485144-2016-00164
    Event Type
    Injury
    Date Received
    July 29, 2016
    Date of Event
    June 27, 2016
    Report Date
    June 29, 2016
    Manufacturer
    BIOMET SPINE - BROOMFIELD
    Product Code
    MAX
    PMA / PMN Number
    PK153695
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. IT IS REPORTED THE HOSPITAL DISCARDED THE DEVICE, THEREFORE NO PRODUCT WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT IS REPORTED DURING A L5-S1 MIS FUSION WITH TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) THE CAGE WOULD NOT EXPAND. THE RELEASE BUTTON ON KNOB WAS ACCIDENTALLY PRESSED AND CAGE WOULD NOT EXPAND. THE CAGE WAS REMOVED AND REPLACED WITH ANOTHER CAGE THAT WORKED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486626 BIOMET SPINE FUSION SYSTEM ZYSTON TRANSFORM 7DEGX25LX11H MAX BIOMET SPINE - BROOMFIELD N/A MD51422

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention