BEUDAMED
    FDA Adverse Event Death Summary report: N

    12MM VBT ANCHOR

    MDR report key: 16845099 · Received May 1, 2023

    Report

    Report Number
    3012447612-2023-00133
    Event Type
    Death
    Date Received
    May 1, 2023
    Report Date
    June 2, 2024
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    QHP
    PMA / PMN Number
    H190005
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 ADDITIONAL METHOD CODE: 4110. CORRECTIONS IN G1. ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. INSPECTION THE DEVICE WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. DHR REVIEW THE LOT NUMBER WAS NOT PROVIDED, SO THE DHR WAS UNABLE TO BE REVIEWED. POTENTIAL ROOT CAUSE A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO UNKNOWN PATIENT OR SURGICAL FACTORS. DEVICE USAGE THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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 3012447612-2023-00129 THROUGH 3012447612-2023-00133.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TETHER PATIENT UNDERWENT A REVISION SURGERY TO BE CONVERTED TO A FUSION AND THE CORD BROKE POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS IS REPORT FIVE OF FIVE FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TETHER PATIENT UNDERWENT A REVISION SURGERY TO BE CONVERTED TO A FUSION AND THE CORD BROKE POST-OPERATIVELY. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS IS REPORT FIVE OF FIVE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666835 12MM VBT ANCHOR THE TETHER - VERTEBRAL BODY TETHERING SYSTEM QHP ZIMMER BIOMET SPINE INC. NA NI
    651796 12MM VBT ANCHOR THE TETHER - VERTEBRAL BODY TETHERING SYSTEM QHP ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention| H