BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDPLATE, LARGE, 3 DEGREES

    MDR report key: 7027697 · Received November 14, 2017

    Report

    Report Number
    3012447612-2017-00640
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    October 30, 2017
    Report Date
    August 3, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MAX
    PMA / PMN Number
    PK132790
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED ENDPLATE WAS EVALUATED. THERE WERE GOUGES AND SCUFF MARKS ON THE DEVICE INDICATIVE OF ATTEMPTED USE. DURING A FUNCTIONAL CHECK, THE ENDPLATE WAS ASSEMBLED AND LOCKED WITH THE MATING STRUT AND ENDPLATE; THERE WAS NOT A DEVICE FAILURE FOUND. THE CAUSE IS LIKELY ATTRIBUTED TO IMPROPER ALIGNMENT OF THE DEVICES OR IMPROPER SEATING ON THE INSERTER DURING ATTEMPTED ASSEMBLY AND LOCKING. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH MAY HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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. REFERENCE REPORTS 3012447612-2017-00640 - 3012447612-2017-00642.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STRUT DID NOT SUCCESSFULLY ASSEMBLE WITH THE TWO MATING END PLATES WITHIN SURGERY. ALL THREE DEVICES WERE REMOVED AND REPLACED WITH ALTERNATIVE DEVICES. THERE WERE NO REPORTS OF PATIENT IMPACTS ASSOCIATED WITH THIS EVENT. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807009 ENDPLATE, LARGE, 3 DEGREES INFIX ANTERIOR LUMBAR SYSTEM MAX ZIMMER BIOMET SPINE INC. NA P204K

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR