BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPINE FUSION SYSTEM

    MDR report key: 5805019 · Received July 19, 2016

    Report

    Report Number
    3004485144-2016-00147
    Event Type
    Injury
    Date Received
    July 19, 2016
    Date of Event
    June 27, 2016
    Report Date
    January 10, 2017
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE 3004485144-2016-00146.

    Additional Manufacturer Narrative · 1

    THE RETURNED INSERTER WAS EXAMINED. THERE WAS NO DAMAGE OR OTHER ISSUES IDENTIFIED DURING VISUAL INSPECTION. IT WAS ALSO FUNCTIONALLY TESTED WITH MATING PARTS AND FOUND TO FUNCTION AS EXPECTED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THERE WERE NO FAILURES DETECTED ON THE INSERTER.

    Description of Event or Problem · 1

    IT IS REPORTED DURING A MIS TLIF (MINIMALLY INVASIVE SURGERY TRANSFORAMINAL LUMBAR INTERBODY FUSION) WHEN THE CAGE WAS IMPACTED INTO THE DISC SPACE THE CAGE WOULD NOT EXPAND AND THE INSERTER COULD NOT BE REMOVED. THE CAGE WAS PULLED OUT AND A DIFFERENT PRODUCT WAS USED TO COMPLETE THE SURGERY. A TWENTY (20) MINUTE SURGICAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456032 BIOMET SPINE FUSION SYSTEM ZYSTON TRANSFORM INSERTER MAX BIOMET SPINE - BROOMFIELD N/A MC46064

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention