BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POL 5.5 TI ROD BENDER

    MDR report key: 5865658 · Received August 10, 2016

    Report

    Report Number
    3004485144-2016-00183
    Event Type
    Malfunction
    Date Received
    August 10, 2016
    Report Date
    June 10, 2018
    Manufacturer
    BIOMET SPINE - BROOMFIELD
    Product Code
    HXW
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS TO ALL FIELDS. FURTHER REVIEW OF THIS EVENT FOUND THAT THIS EVENT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. THIS EVENT WOULD NOT LIKELY LEAD TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE IS HXP (NOT AVAILABLE ON DROP DOWN LIST). 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 EVALUATED. THE BENDING MECHANISM IS LOOSE WHICH MAKES ROD BENDING DIFFICULT. THE COMPLAINT IS CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THE CAUSE OF THE ISSUE IS ATTRIBUTED TO WEAR FROM INTENSIVE USE OVER TIME.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED A LOOSE BENDER. WHEN IT WAS TIME TO PLACE RODS, THE SURGEON CALLED FOR A ROD AND THE FRENCH BENDERS. WHEN HE WENT TO UTILIZE THE BENDERS, THEY WERE EXTREMELY LOOSE AND MADE BENDING THE ROD EXTREMELY DIFFICULT. IT WAS LOOSE AT THE JOINT, SO THAT IF YOU WERE HOLDING THE BENDER ARMS IN YOUR RIGHT AND LEFT HAND, YOU WERE ABLE TO MOVE THEM IN A CEPHALAD/CAUDAL PLANE, WHICH NORMALLY YOU SHOULD BE UNABLE TO DO SO. SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519054 POL 5.5 TI ROD BENDER ROD BENDER HXW BIOMET SPINE - BROOMFIELD N/A 087172

    Patients

    Seq Age Sex Outcome Treatment
    1