BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POL 5.5 TI THOR PED PROBE G3

    MDR report key: 6045611 · Received October 20, 2016

    Report

    Report Number
    3004485144-2016-00288
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    September 28, 2016
    Report Date
    March 30, 2017
    Manufacturer
    ZIMMER BIOMET SPINE
    Product Code
    HXB
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 DEVICE WAS EXAMINED. THE CURVED SECTION OF THE TIP WAS FOUND TO HAVE FRACTURED OFF AND WAS NOT RETURNED; 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 SUFFICIENT INSTRUCTIONS REGARDING PROPER DEVICE USAGE. THE CAUSE OF THE EVENT IS UNKNOWN. FURTHER EVENT DETAILS WERE REQUESTED FROM THE REPORTER BUT NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A PEDICLE PROBE BROKE OFF WITHIN THE PATIENT DURING A T10-PELVIS FUSION PROCEDURE. THE TIP WAS NOT ABLE TO BE REMOVED FROM THE PATIENT; THE PATIENT RETAINED A FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696754 POL 5.5 TI THOR PED PROBE G3 PROBE HXB ZIMMER BIOMET SPINE N/A 562096

    Patients

    Seq Age Sex Outcome Treatment
    1 Other