BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RONGEUR PITUITARY CER BLACK SERRATED 3MM

    MDR report key: 7148061 · Received December 27, 2017

    Report

    Report Number
    3012447612-2017-00697
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    October 26, 2017
    Report Date
    December 27, 2017
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HTX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CROSS PIN BROKE ON A RONGEUR WHILE REMOVING DISC MATERIAL DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE RONGEUR. THERE WERE NO REPORTS OF PATIENT IMPACTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927050 RONGEUR PITUITARY CER BLACK SERRATED 3MM RONGEUR HTX ZIMMER BIOMET SPINE INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1