BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA OPEN CLOSURE, 5.5M, TOP TI

    MDR report key: 11773494 · Received May 4, 2021

    Report

    Report Number
    3012447612-2021-00165
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 2, 2021
    Report Date
    June 11, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    UDI-DI
    00889024334861
    PMA / PMN Number
    K131980
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN: H6: COMPONENT CODES, TYPE OF INVESTIGATIONS, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: VISUAL INSPECTION REVEALS THAT ONE HAS DAMAGED OUTER THREADS AND THE OTHER HAS DAMAGED HEX SO THAT THE HEX IS DIFFICULT TO RECOGNIZE. POTENTIAL CAUSE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO WEAR THROUGH USE OVER TIME OR MULTIPLE STERILIZATION CYCLES. DHR REVIEW PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. NO ACTIONS REQUIRED. DEVICE USE AND COMPATIBILITY THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO CLOSURE TOPS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THE CLOSURE TOPS WERE REMOVED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED IMPACT ON THE PATIENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    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. REFERENCE REPORT 3012447612-2021-00164.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO CLOSURE TOPS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THE CLOSURE TOPS WERE REMOVED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED IMPACT ON THE PATIENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667534 SEQUOIA OPEN CLOSURE, 5.5M, TOP TI SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM NKB ZIMMER BIOMET SPINE INC. N/A ABB 00889024334861

    Patients

    Seq Age Sex Outcome Treatment
    1