BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA OPEN CLOSURE, 5.5M, TOP TI

    MDR report key: 11697740 · Received April 20, 2021

    Report

    Report Number
    3012447612-2021-00133
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 25, 2021
    Report Date
    June 23, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    UDI-DI
    0088902433486
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND INITIALLY CORRECTED INFORMATION. SUMMARY: THE COMPLAINT IS CONFIRMED FOR TWO (2) OF THREE (3) RETURNED SEQUOIA CLOSURE TOP (PN 3301-1) FOR THE FAILURE OF CLOSURE TOP DRIVER POCKET(HEX) STRIPPED DURING OPERATION, AND THE COMPLAINT IS CONFIRMED FOR THREE(3)OF THREE(3) RETURNED SEQUOIA CLOSURE TOP (PN 3301-1) FOR THE FAILURE OF CLOSURE TOPS BEING STRIPPED DURING OPERATION. ALL RETURNED ITEMS HAD DAMAGED THREADS. TWO OF THE ITEMS HAD LOST THEIR HEX SHAPE. THE THIRD ITEM HAD DAMAGED OUTER THREADS. POTENTIAL CAUSE: THE CAUSE OF THE DAMAGE CANNOT BE DETERMINED AT THIS TIME SINCE THERE IS NO INFORMATION AVAILABLE REGARDING HOW THE CLOSURE TOPS WERE BEING USED OR HANDLED AT THE TIME OF THE DAMAGE. DHR REVIEW AND RELATED ACTIONS: PER DHRS REVIEW, THE PARTS WERE LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. NO ACTIONS REQUIRED. THIS EVENT IS NOT RELATED TO ANY CURRENT ACTIONS OR RECALLS OR PRODUCT HOLDS. DEVICE USE: THESE DEVICES ARE 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 THREE CLOSURE TOPS WERE STRIPPED DURING FINAL TORQUEING. ANOTHER CLOSURE TOP WAS USED TO COMPLETE THE SURGERY. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS REPORT 2 OF 3 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 REPORTS 3012447612-2021-00132 TO 3012447612-2021-00134.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE CLOSURE TOPS WERE STRIPPED DURING FINAL TORQUEING. ANOTHER CLOSURE TOP WAS USED TO COMPLETE THE SURGERY. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS REPORT 2 OF 3 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590491 SEQUOIA OPEN CLOSURE, 5.5M, TOP TI SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM NKB ZIMMER BIOMET SPINE INC. N/A ABA 0088902433486

    Patients

    Seq Age Sex Outcome Treatment
    1