BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARDIS PEEK IMPLANT 12X09X22

    MDR report key: 6033237 · Received October 17, 2016

    Report

    Report Number
    3004485144-2016-00276
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    September 26, 2016
    Report Date
    June 2, 2017
    Manufacturer
    ZIMMER BIOMET SPINE
    Product Code
    MAX
    PMA / PMN Number
    PK133184
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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.

    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.

    Additional Manufacturer Narrative · 1

    THE RETURNED SPACER WAS EXAMINED. A PORTION HAS FRACTURED OFF AT THE THREADED INSERTION POINT, WHICH MAY BE ATTRIBUTED TO OFF-AXIS FORCES PLACED ON THE DEVICE WITH THE INSERTER DURING INSERTION. THE COMPLAINT IS CONFIRMED. 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 INSTRUCTIONS REGARDING PROPER DEVICE USAGE, INCLUDING INSERTION.

    Description of Event or Problem · 1

    THE SURGEON SIZED FOR A 12MM HIGH CAGE IN THE PATIENT'S L3-4 DISC SPACE. A 12X9X22MM CAGE WAS ATTACHED TO THE INSERTER. AFTER IMPACTING THE INSERTER TWO TIMES WITH A MALLET, THE BACK OF THE CAGE BROKE AND CAME OFF OF THE INSERTER. THE PATIENT DID NOT RETAIN ANY PIECES OF THE BROKEN CAGE. THERE WAS A SURGICAL DELAY OF 5 MINUTES, BUT THERE WAS NO REPORTED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684771 ARDIS PEEK IMPLANT 12X09X22 ARDIS INTERBODY SYSTEM MAX ZIMMER BIOMET SPINE N/A 2380441

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention