BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POL 5.5 TI FLEXIBLE PED SOUND

    MDR report key: 6088860 · Received November 9, 2016

    Report

    Report Number
    3004485144-2016-00303
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 12, 2016
    Report Date
    November 9, 2016
    Manufacturer
    ZIMMER BIOMET SPINE
    Product Code
    HXB
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A FLEXIBLE SOUNDER BROKE OFF IN THE PATIENT'S VERTEBRAL BODY DURING A PROCEDURE AND HAD TO BE REMOVED. THE PATIENT DID NOT RETAIN A FOREIGN BODY AND NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742225 POL 5.5 TI FLEXIBLE PED SOUND PROBE HXB ZIMMER BIOMET SPINE N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention