BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSURE TOP

    MDR report key: 17105778 · Received June 12, 2023

    Report

    Report Number
    3012447612-2023-00194
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 26, 2023
    Report Date
    May 20, 2024
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    UDI-DI
    00889024334861
    PMA / PMN Number
    K131980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 3012447612-2023-001945 THROUGH 3012447612-2023-00196.

    Additional Manufacturer Narrative · 0

    COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE RETURNED DEVICE MATCHES THE INFORMATION IN THE COMPLAINT FILE AND WAS EXAMINED. VISUAL INSPECTION REVEALED THE HEX IS STRIPPED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO OFF-AXIS FORCES APPLIED DURING USE. DHR REVIEW: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT HIGHRIDGE CONTROL. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE CLOSURE TOPS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THEY WERE REMOVED AND REPLACED WITH OTHER CLOSURE TOPS. THERE WAS A DELAY OF 30 MINUTES, BUT THERE WERE NO PATIENT IMPACTS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE CLOSURE TOPS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THEY WERE REMOVED AND REPLACED WITH OTHER CLOSURE TOPS. THERE WAS A DELAY OF 30 MINUTES, BUT THERE WERE NO PATIENT IMPACTS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267944 CLOSURE TOP SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM NKB ZIMMER BIOMET SPINE INC. NA ABH 00889024334861

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose