BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULATING ARM LATERAL

    MDR report key: 6126445 · Received November 23, 2016

    Report

    Report Number
    3004485144-2016-00334
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    October 27, 2016
    Report Date
    June 2, 2017
    Manufacturer
    ZIMMER BIOMET SPINE
    Product Code
    LHX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 EVALUATED. THE OUTER JOINTS WOULD NOT LOCK INTO POSITION WHEN THE KNOB WAS TIGHTENED; THE COMPLAINT IS CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. REFERENCE REPORT 3012447612-2017-00164.

    Description of Event or Problem · 1

    WHILE OPERATING, THE ARTICULATING ARM STOPPED TIGHTENING. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Description of Event or Problem · 1

    WHILE OPERATING, THE ARTICULATING ARM STOPPED TIGHTENING. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777028 ARTICULATING ARM LATERAL ARTICULATING ARM LHX ZIMMER BIOMET SPINE N/A L562888

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR