BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPINE FUSION SYSTEM

    MDR report key: 5805017 · Received July 19, 2016

    Report

    Report Number
    3004485144-2016-00146
    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. (B)(4). REPORT ONE OF TWO FOR THE SAME EVENT, REFERENCE 3004485144-2016-00147.

    Additional Manufacturer Narrative · 1

    THE RETURNED CAGE WAS EXAMINED. THERE IS SOME DEFORMATION ON THE INSERTER CONNECTION THREADS. THE CAUSE OF THE DEFORMATION CANNOT BE CONCLUSIVELY DETERMINED. WHEN THE CAGE WAS FUNCTIONALLY TESTED WITH A MATING INSERTER, THERE WAS DIFFICULTY THREADING THEM TOGETHER BECAUSE OF THE DEFORMATION, WHICH MAY HAVE CONTRIBUTED TO THE EVENT AS THE INSERTER MUST BE ALIGNED IN THE CAGE PROPERLY FOR THE CAGE TO EXPAND. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN ADEQUATE INSTRUCTIONS REGARDING PROPER DEVICE USAGE.

    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
    456031 BIOMET SPINE FUSION SYSTEM ZYSTON TRANSFORM 7DEGX25LX7H MAX BIOMET SPINE - BROOMFIELD N/A MD51418

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention