BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQ POLY SCREW ASSY 6.5 X 45

    MDR report key: 6126411 · Received November 23, 2016

    Report

    Report Number
    3004485144-2016-00325
    Event Type
    Injury
    Date Received
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    ZIMMER BIOMET SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK131980
    Removal / Correction Number
    N/A
    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. 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

    THE SURGEON WAS ATTEMPTING TO CHANGE THE POSITION OF THE CAGE BETWEEN L4 AND L5 USING REDUCTION FORCEPS WHEN THE HEAD OF THE POLYAXIAL SCREW DISASSOCIATED FROM THE SHAFT. THE OPERATION WAS FINISHED USING AN ALTERNATIVE SCREW. NO PATIENT HARM OR SURGICAL DELAY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775418 SEQ POLY SCREW ASSY 6.5 X 45 SEQUOIA (PEDICAL SCREW SYSTEM) NKB ZIMMER BIOMET SPINE N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention