BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KERRISON RONGEUR(40° FWD)4MM

    MDR report key: 5974615 · Received September 23, 2016

    Report

    Report Number
    0002184052-2016-00230
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Report Date
    August 26, 2016
    Manufacturer
    ZIMMER SPINE
    Product Code
    HTX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    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. DEVICE PRODUCT CODE: HTX.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED A BUSTED RONGEUR. THERE WAS NO SURGERY OR PATIENT INVOLVED, HOWEVER IT IS REPORTED THIS OCCURRED OVER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626843 KERRISON RONGEUR(40° FWD)4MM KERRISON RONGEUR(40° FWD)4MM HTX ZIMMER SPINE N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1